FDA.reportPublic FDA data

First Aid Only First Aid/Burn

Product NDC
0924-5011
11-digit product format
009245011
Labeler code
0924
Product ID
0924-5011_27225914-f582-736b-e063-6394a90ad1c5
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride and Benzalkonium Chloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Acme United Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-30
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
5; 1.3 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
First Aid Only First Aid/Burn
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/g
BENZALKONIUM CHLORIDE1.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012100Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
caa67a05-bdbd-c380-e053-2995a90a0bf1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5011-00First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-01First Aid Only First Aid/Burn10 in 1 CARTONCREAM102
0924-5011-01First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn12 in 1 CARTONCREAM122
0924-5011-03First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-03First Aid Only First Aid/Burn25 in 1 CARTONCREAM252
0924-5011-04First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-04First Aid Only First Aid/Burn144 in 1 CARTONCREAM1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5011FIRST AID ONLY FIRST AID/BURN (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) CREAM [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 9 package rows20241119_caa67a05-bdbd-c380-e053-2995a90a0bf1.zip

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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNcaa67a05-bdbd-c380-e053-2995a90a0bf12
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDcaa67a05-bdbd-c380-e053-2995a90a0bf12
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYcaa67a05-bdbd-c380-e053-2995a90a0bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-5011-0000924501100.9 g in 1 PACKET (0924-5011-00) 2021-08-300000-00-00NoNoCurrent
0924-5011-010092450110110 PACKET in 1 CARTON (0924-5011-01) / .9 g in 1 PACKET10 packet2021-08-300000-00-00NoNoCurrent
0924-5011-020092450110212 PACKET in 1 CARTON (0924-5011-02) / .9 g in 1 PACKET12 packet2021-08-300000-00-00NoNoCurrent
0924-5011-030092450110325 PACKET in 1 CARTON (0924-5011-03) / .9 g in 1 PACKET25 packet2021-08-300000-00-00NoNoCurrent
0924-5011-0400924501104144 PACKET in 1 CARTON (0924-5011-04) / .9 g in 1 PACKET144 packet2021-08-300000-00-00NoNoCurrent