FDA.reportPublic FDA data

First Aid Only First Aid-Burn

Product NDC
0924-5702
11-digit product format
009245702
Labeler code
0924
Product ID
0924-5702_2990220d-65fc-79b0-e063-6394a90a1736
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Acme United Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-30
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 5 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

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
BENZALKONIUM CHLORIDE1.3 mg/g
LIDOCAINE HYDROCHLORIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

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
0924-5702-00First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn6 in 1 CARTONCREAM64
0924-5702-02First Aid Only First Aid-Burn10 in 1 CARTONCREAM104
0924-5702-02First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-03First Aid Only First Aid-Burn12 in 1 CARTONCREAM124
0924-5702-03First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-04First Aid Only First Aid-Burn20 in 1 CARTONCREAM204
0924-5702-04First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn25 in 1 CARTONCREAM254
0924-5702-06First Aid Only First Aid-Burn60 in 1 CARTONCREAM604
0924-5702-06First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn144 in 1 CARTONCREAM1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5702FIRST AID ONLY FIRST AID-BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [ACME UNITED CORPORATION]4Current NDC, 15 package rows20241220_f31a44ff-e4ac-de1e-e053-2a95a90ab036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf31a44ff-e4ac-de1e-e053-2a95a90ab0364
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf31a44ff-e4ac-de1e-e053-2a95a90ab0364
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf31a44ff-e4ac-de1e-e053-2a95a90ab0364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5702-0000924570200.9 g in 1 PACKET (0924-5702-00) 2023-01-30NoNoCurrent
0924-5702-01009245702016 PACKET in 1 CARTON (0924-5702-01) / .9 g in 1 PACKET6 packet2024-12-31NoNoCurrent
0924-5702-020092457020210 PACKET in 1 CARTON (0924-5702-02) / .9 g in 1 PACKET10 packet2024-12-31NoNoCurrent
0924-5702-030092457020312 PACKET in 1 CARTON (0924-5702-03) / .9 g in 1 PACKET12 packet2024-12-31NoNoCurrent
0924-5702-040092457020420 PACKET in 1 CARTON (0924-5702-04) / .9 g in 1 PACKET20 packet2024-12-31NoNoCurrent
0924-5702-050092457020525 PACKET in 1 CARTON (0924-5702-05) / .9 g in 1 PACKET25 packet2024-12-31NoNoCurrent
0924-5702-060092457020660 PACKET in 1 CARTON (0924-5702-06) / .9 g in 1 PACKET60 packet2024-12-31NoNoCurrent
0924-5702-0700924570207144 PACKET in 1 CARTON (0924-5702-07) / .9 g in 1 PACKET144 packet2024-12-31NoNoCurrent