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 13 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Methol Pain ReliefMENTHOL 10.5 %Sunflora Inc6ddd9e97-f717-4d5a-9658-26449a3cc8312026-07-02WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEAmerisourceBergen Drug Corporation7d898e33-ded7-c9b9-e053-2a91aa0adf7c2026-07-01WarningsExact identifier
application number: M017
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsExact identifier
application number: M017
CVS No Mess CortisoneHYDROCORTISONENatural Essentials, Inc.558c94ec-95f1-eb98-e063-6394a90a1e722026-07-01WarningsExact identifier
application number: M017
MUSCLE EASEMENTHOL CAMPHORSOMBRA COSMETICS INC.03fff4bf-04ed-49a6-b40f-4d98c2b42f692026-07-01WarningsExact identifier
application number: M017
OrthoNesic Pain Relieving GelMENTHOL, CAMPHORBlaine Labs Inc.122f60c2-f8df-4625-8bb8-a2244a261b5d2026-07-01WarningsExact identifier
application number: M017
Desert Harvest RELEVEUMLIDOCAINEDesert Harvest Inc.5d9010ec-d482-44ff-ba27-3bfec5a241c62026-06-30WarningsExact identifier
application number: M017
PromescentLIDICAINEAbsorption5b508238-3be7-4b0d-bf35-51de79f58f552026-06-30WarningsExact identifier
application number: M017
LidovyxLIDOCAINE 4%V2 Pharma LLC4465eb60-a617-4608-9504-8b3b4c64f49e2026-06-30WarningsExact identifier
application number: M017
Dr.Johnes Lidocaine 4% Topical Analgesic CreamLIDOCAINE HCL,MENTHOLDr.Johnes LLC6144708d-4b0f-4f0d-88e3-6925ba2d004d2026-06-29WarningsExact identifier
application number: M017
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact 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