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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A Health Itch Relief GelITCH RELIEF GELPharma Nobis, LLC4f80c403-c760-31ec-e063-6394a90a61c92026-04-15WarningsExact identifier
application number: M017
Family Care Antibiotic Pain Relief 0.33ozANTIBIOTIC PAIN RELIEFUnited Exchange Corp4f8405fc-3e38-05d9-e063-6394a90a4cda2026-04-15WarningsExact identifier
application number: M017
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
application number: M017
LavaDerm AfterSunMENTHOLYoung Living Essential Oils, LC.4fcddcf1-36db-2f1a-e054-00144ff8d46c2026-04-15WarningsExact identifier
application number: M017
Arlun Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f8b60f9-03e3-e731-e063-6294a90a3b0a2026-04-15WarningsExact identifier
application number: M017
tuiwaro Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.4f66178c-95d9-8c6a-e063-6294a90a2c092026-04-14WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONPharma Nobis, LLC4f6f5a0b-3bfa-289e-e063-6294a90a94b32026-04-14WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
application number: M017
Signature Pain Relief Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4f555b8f-5193-e685-e063-6294a90a7ba22026-04-13WarningsExact identifier
application number: M017
Deep Numbing CreamMENTHOLYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD7943559b-de10-4214-96dc-f9cbac828f462026-04-13WarningsExact identifier
application number: M017
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1% WITH ALOEPublix Super Markets Inc.3c45a654-7fec-55b3-e063-6294a90a184b2026-04-13WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%AMERISOURCE BERGEN4f5aea1c-ae51-4e1a-e063-6294a90a6aa12026-04-13WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8465b443-abe9-78fb-e053-2a91aa0ac1d82026-04-13WarningsExact identifier
application number: M017
4JointzMENTHOLARP(USA) Pty Ltd94a5b5f5-abf7-40b3-9dd7-43e2c22f138e2026-04-13WarningsExact identifier
application number: M017
Sumifun Pain Relief CreamsMETHYL SALICLATE CAPSAICIN CAMPHORGuchutang Biotechnology (Longyan) Co., Ltd4f3dd96a-d843-d810-e063-6394a90a188e2026-04-12WarningsExact identifier
application number: M017
BonicaEaseX 24 Hour Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co., Ltd.17fc0cd1-710d-45e6-9513-d7100e3adb422026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltdacf460b4-1b41-4b30-a74a-6c3613119d8e2026-04-10WarningsExact identifier
application number: M017
BonicaEaseX Menthol Pain RelievingMENTHOL, UNSPECIFIED FORMPlanet (Anhui) Pharmaceutical Co.,Ltd4d84b4fb-8f55-4b2b-b261-858edb7f31442026-04-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Gel PatchCAPSAICIN, MENTHOLVeridian Healthcaref5484151-b6da-4f64-867f-87160a4ec2d62026-04-10WarningsExact 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