FDA.reportPublic FDA data

First Aid Only Burn

Product NDC
0924-5010
11-digit product format
009245010
Labeler code
0924
Product ID
0924-5010_27223959-ea8a-210b-e063-6294a90a4bc6
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Acme United Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-02
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 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

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid Only Burn
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011852

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5010-00First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-01First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-01First Aid Only Burn6 in 1 CARTONGEL62
0924-5010-02First Aid Only Burn3.5 g in 1 PACKETGEL3.52
0924-5010-02First Aid Only Burn25 in 1 CARTONGEL252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5010FIRST AID ONLY BURN (LIDOCAINE HYDROCHLORIDE) GEL [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 5 package rows20241119_9af39fcd-0a57-26d0-e053-2a95a90a99a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN9af39fcd-0a57-26d0-e053-2a95a90a99a02
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD9af39fcd-0a57-26d0-e053-2a95a90a99a02
1011852lidocaine hydrochloride 2 % Topical JellySY9af39fcd-0a57-26d0-e053-2a95a90a99a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-5010-00009245010003.5 g in 1 PACKET (0924-5010-00) 3.5 g2020-01-020000-00-00NoNoCurrent
0924-5010-01009245010016 PACKET in 1 CARTON (0924-5010-01) / 3.5 g in 1 PACKET6 packet2020-01-020000-00-00NoNoCurrent
0924-5010-020092450100225 PACKET in 1 CARTON (0924-5010-02) / 3.5 g in 1 PACKET25 packet2020-01-020000-00-00NoNoCurrent