Lidocaine Anesthetic Cream

Product NDC
69375-005
Requested package NDC
69375-005-30
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 112 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b6c3d6eb-b485-33b8-e053-2a95a90a41e12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b4cd4fed-e8c8-db85-e053-2995a90a708b2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain Relief LiquidMENTHOL 16%Tommie Copper, Inc.c93a0139-953b-5523-e053-2a95a90a0b2d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.ca011b03-a263-1908-e053-2995a90ad9702024-12-15WarningsExact identifier
application number: M017
Warrior Chiggerex ReliefBENZOCAINE 10%Derma Care Research Labs, LLCdcf2f52b-2295-58e5-e053-2995a90a7fd82024-12-15WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLCdef8d341-06a7-0e9b-e053-2995a90a0ad62024-12-13WarningsExact identifier
application number: M017
Mentholatum OriginalCAMPHOR, MENTHOLThe Mentholatum Company19e4b812-67c6-49fd-833a-b432100363f52024-12-13WarningsExact identifier
application number: M017
Cold and Hot MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
application number: M017
Mentholatum Lidocaine IceLIDOCAINE HCL, MENTHOLThe Mentholatum Company4d74cbab-31cd-4579-9360-6852ee215b5e2024-12-13WarningsExact identifier
application number: M017
Mentholatum Deep Heating Rub Extra StrengthMENTHOL, METHYL SALICYLATEThe Mentholatum Companyf5684158-0d83-4031-b493-5422ddc73e782024-12-13WarningsExact identifier
application number: M017
Discount Drug Mart Anti-ItchCAMPHOR, MENTHOLDiscount Drug Mart87d379da-103a-c751-e053-2995a90a56de2024-12-13WarningsExact identifier
application number: M017
Audiologist Anti-itchHYDROCORTISONEOAKTREE PRODUCTS, INC.853e078e-1e91-d55f-e053-2991aa0a6dcd2024-12-13WarningsExact identifier
application number: M017
CVS Anti itchHYDROCORTISONECVS884df604-711b-4a3d-e053-2995a90a3a042024-12-13WarningsExact identifier
application number: M017
Dermoplast Pain RelievingBENZOCAINE AND LEVOMENTHOLAdvantice Health, LLC2347f0b8-d463-422d-8583-65624d9a1a912024-12-12WarningsExact identifier
application number: M017
HealthWise Medicated Foot PowderMENTHOLVeridian Healthcare2916a0c3-2d66-d079-e063-6394a90acd6b2024-12-12WarningsExact identifier
application number: M017
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
application number: M017
Natural Seal Itch Relief for KidsLIDOCAINEKericure Inc.31cc0c95-5864-4737-b085-8f58e00f4f052024-12-12WarningsExact identifier
application number: M017
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Creme Maximum StrengthBENZOCAINE AND RESORCINOLCombe Incorporatedbb73ebd7-ceb0-4b54-9e8f-77486d9037fb2024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Creme Regular StrengthBENZOCAINE AND RESORCINOLCombe Incorporateddd303ff8-0deb-4292-bfd8-5bda91f86d512024-12-12WarningsExact 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