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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017
The Best Numbing CreamTBNCThe Best Numbing Cream LLC4ca3923b-f586-0aaf-e063-6294a90a16c12026-03-31WarningsExact identifier
application number: M017
ChapStick Classic MedicatedEXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALMSuave Brands Co., LLC42798a6c-2d7e-80f6-e063-6294a90a105f2026-03-31WarningsExact identifier
application number: M017
Roll-On Pain Relief LiquidLIDOCAINE HCLHyVee Inc4da6f6fb-b182-360f-e063-6294a90abdf32026-03-31WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4e54aecb-190f-3866-e063-6294a90a810a2026-03-31WarningsExact identifier
application number: M017
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
application number: M017
ZENOL COOLMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4e5c45f4-88ce-3a13-e063-6394a90a2a092026-03-31WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited091451fb-e30a-0012-e063-6394a90a3ba82026-03-31WarningsExact identifier
application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and MintMENTHOLChattem, Inc.b16ba9c2-23bf-4fdf-b44b-7abb9fec19112026-03-31WarningsExact identifier
application number: M017
DR.PABU NUMBINGLIDOCAINE 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4e3a3c6c-4821-76ea-e063-6294a90a8f962026-03-30WarningsExact identifier
application number: M017
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsExact identifier
application number: M017
CVS Muscle Balm and Roll-OnCAMPHOR, MENTHOLCVS Pharmacy4e40025a-070a-508e-e063-6394a90af5d72026-03-30WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLCc3eec066-38e8-4617-b34d-2f72ffb7a3242026-03-30WarningsExact identifier
application number: M017
Softlips Naturals Medicated Matcha HoneyCAMPHOR, MENTHOLThe Mentholatum Company4e03a721-73f3-b2f2-e063-6394a90a44e62026-03-27WarningsExact 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