FDA.reportPublic FDA data

Lidocaine Anesthetic Cream

Product NDC
69375-005
11-digit product format
693750005
Labeler code
69375
Product ID
69375-005_58ef10f7-2fa2-4c38-8b3f-f5df87cf4e4e
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Nationwide Pharmaceutical LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-01
Substance
LIDOCAINE
Active strength
4 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Anesthetic Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69375-005-302024-01-31C16284748780-11030e365-4ceb-111a-e063-dadaa90a10e2Lidocaine Cream
69375-005-302024-01-31C16284748780-11030e365-4ceb-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69375-005-30Lidocaine Anesthetic Cream28 g in 1 TUBECREAM284
69375-005-30Lidocaine Anesthetic Cream1 in 1 BOXCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69375-005-30GM - Gram69375-00511618954-a617-405b-94c8-2c5c073600db12022-07-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 100 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017
VTROUY Tattoo Numbing CreamTATTOO NUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2e899851-b3cd-0758-e063-6294a90afea82025-02-19WarningsExact identifier
application number: M017
Pomada Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATEGenomma Lab USA9d98f48b-6d88-4df9-9459-7cf7ba5de0442025-02-19WarningsExact identifier
application number: M017
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, RegularALUMINUM CHLOROHYDRATESodalis USA, LLC7839cf53-dbd2-4dbb-a309-1581d51f8adc2025-02-18WarningsExact identifier
application number: M017
CANNA NUMB Roll OnLIDOCAINE HYDROCHLORIDE, MENTHOLCannanumb LLCc1eb0348-3b0e-4f1c-a46b-1ff4aa165fb42025-02-17WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
application number: M017
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOREVI LABSEVI LABS2df7658d-83d3-41ac-e063-6294a90ab1dd2025-02-12WarningsExact identifier
application number: M017
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421893lidocaine 4 % Topical CreamPSNdcc5a175-97a0-4e5f-a74d-1a7059d0bfff4
1421893lidocaine 40 MG/ML Topical CreamSCDdcc5a175-97a0-4e5f-a74d-1a7059d0bfff4
1421893lidocaine 4 % Topical CreamSYdcc5a175-97a0-4e5f-a74d-1a7059d0bfff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69375-005-30693750005301 TUBE in 1 BOX (69375-005-30) / 28 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent