ACNE SPOT TREATMENT

Product NDC
61328-404
11-digit product format
613280404
Labeler code
61328
Product ID
61328-404_483368a7-95f2-5d8d-e063-6394a90a232e
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-16
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACNE SPOT TREATMENT
Brand name suffix
2% BHA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui317152

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-404-05ACNE SPOT TREATMENT2% BHA15 mL in 1 TUBECREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-404ACNE SPOT TREATMENT 2% BHA (SALICYLIC ACID) CREAM [SKINFIX, INC.]3Current NDC, Legacy NDC, 1 package rows20241228_ceccea68-07d8-0903-e053-2995a90ab2b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNceccea68-07d8-0903-e053-2995a90ab2b75
317152salicylic acid 20 MG/ML Topical CreamSCDceccea68-07d8-0903-e053-2995a90ab2b75
317152salicylic acid 2 % Topical CreamSYceccea68-07d8-0903-e053-2995a90ab2b75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61328-404-056132804040515 mL in 1 TUBE (61328-404-05) 15 ml2021-03-160000-00-00NoNoCurrent