14% Azelaic Acid Acne

Product NDC
84753-056
11-digit product format
847530056
Labeler code
84753
Product ID
84753-056_4ccaa734-83bf-611b-e063-6294a90ab3bf
Type
HUMAN OTC DRUG
Nonproprietary name
Azelaic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangdong Bisutang Biotechnology Co., Ltd.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-12
Substance
AZELAIC ACID
Active strength
14 g/100g
Pharmacologic classes
Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
14% Azelaic Acid Acne
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELAIC ACID14 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2VW3D43YT
Rxcui2738813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84753-056-0114% Azelaic Acid Acne30 g in 1 BOTTLECREAM301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2738813azelaic acid 14 % Topical CreamPSN4ccaa734-83be-611b-e063-6294a90ab3bf1
2738813azelaic acid 140 MG/ML Topical CreamSCD4ccaa734-83be-611b-e063-6294a90ab3bf1
2738813azelaic acid 14 % Topical CreamSY4ccaa734-83be-611b-e063-6294a90ab3bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84753-056-018475300560130 g in 1 BOTTLE (84753-056-01) 30 g2026-03-12NoNoHistorical