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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact 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