FDA.reportPublic FDA data

GENUINE FIRST AID Antiseptic Pain Relieving

Product NDC
43473-015
11-digit product format
434730015
Labeler code
43473
Product ID
43473-015_0814dd5c-45ab-739e-e063-6394a90ac8bc
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-19
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
.13; .5 g/100g; g/100g
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
GENUINE FIRST AID Antiseptic Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
LIDOCAINE HYDROCHLORIDE ANHYDROUS.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, EC2CNF7XFP
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
43473-015-01GENUINE FIRST AID Antiseptic Pain Relieving0.9 g in 1 POUCHCREAM0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43473-015GENUINE FIRST AID ANTISEPTIC PAIN RELIEVING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.]1Current NDC, 1 package rows20231020_bc7c6739-6068-4694-adc9-0c0c5c347df4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNbc7c6739-6068-4694-adc9-0c0c5c347df41
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDbc7c6739-6068-4694-adc9-0c0c5c347df41
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYbc7c6739-6068-4694-adc9-0c0c5c347df41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43473-015-0143473001501.9 g in 1 POUCH (43473-015-01) 2023-10-19NoNoCurrent