Lidocaine is an over-the-counter medicine (Amide Local Anesthetic; Antiarrhythmic). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Recent recall — 2 ongoing recalls reported in the last 90 days. Only the lots listed are affected. Details
- Type
- Over the counter (OTC)
- Brand names
- Pain Relief Patches, Pain Relieving Gel-Patch, Burn Relief, Dr. Numb, Numb 520, Numbing Cream, Signature numbing cream, Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream, Numb25, Pain Relief Gel-Patch, 5% Signature Numb cream, Burn
- Drug class
- Amide Local Anesthetic; Antiarrhythmic
- Taken
- Topical
- Label
- Chelsea Pharmacceuticals LLC, revised September 10, 2026 · full label on DailyMed
Purpose
Local Anesthetic (anorectal)
What it is used for
Helps relieve the local itching and discomfort in the perianal area. For the temporary relief of pain, irritation or burning.
Active ingredient
Lidocaine 5.00 % Purpose Local Anesthetic (anorectal)
Do not use
Do Not Exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using your fingers or any mechanical device or applicator.
When using this product
If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly.
Stop use and ask a doctor if
If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product.
Warnings
For external use only Do Not Exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using your fingers or any mechanical device or applicator. When using this product If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Lidocaine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05
Reason: Failed Content Uniformity Specifications
Lots, distribution and details
- Lots / codes
- Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
- Distribution
- USA Nationwide
- Quantity
- N/A
- Recall started
- September 28, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2027
-
Class II Ongoing
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5
Reason: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Lots, distribution and details
- Lots / codes
- Lot # AD48154, Exp: 4/30/2027.
- Distribution
- Nationwide in the USA
- Quantity
- 65,328 50g jars
- Recall started
- August 31, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0848-2026
-
Class II Ongoing
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0822-2023
-
Class III Ongoing
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories…
Reason: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Lots, distribution and details
- Product
- Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
- Lots / codes
- Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 403 boxes
- Recall started
- April 20, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0556-2023
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Lidocaine
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID b8a589f7-7131-4807-9bcb-84af3078e258.