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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 14% Azelaic Acid Acne
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AZELAIC ACID | 14 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F2VW3D43YT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2738813 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4ccaa734-83be-611b-e063-6294a90ab3bf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 6c6fc281-9445-2e9e-1c29-a09ddbc4299c | Product name | 2 | 20200213 |
| 2a856070-cbe7-4f85-be0f-09885ff91196 | Product name | 1 | 20150806 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84753-056-01 | 14% Azelaic Acid Acne | 30 g in 1 BOTTLE | CREAM | 30 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment | SALICYLIC ACID | SICOS ET CIE | 6e366dc4-288a-47b1-ab72-8ed3aa6aea22 | 2026-03-02 | Warnings | M006 |
| Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment | SALICYLIC ACID | LOreal USA Products Inc | c5ce4ec6-176f-4bb0-96f0-6817e53c1468 | 2026-03-02 | Warnings | M006 |
| FOLUPIA MILIA REMOVER | SALICYLIC ACID 1% MILIA REMOVER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4bca1a8b-2df4-47b1-e063-6394a90a33ff | 2026-02-27 | Warnings | M006 |
| Medicated Apricot Scrub | SALICYLIC ACID | Walmart Inc. | 56e29d46-a29d-4192-9fdf-58dbcb843d44 | 2026-02-27 | Warnings | M006 |
| Acne Treatment | BENZOYL PEROXIDE | Walmart Inc. | 950edb4e-fbba-41e3-9ec5-973806e555e7 | 2026-02-27 | Warnings, Adverse reactions | M006 |
| Body Wash | SALICYLIC ACID | Walmart Inc. | c31a5629-66c3-47a7-96ea-9987b2be82af | 2026-02-27 | Warnings, Adverse reactions | M006 |
| Acne Control Cleanser | SALICYLIC ACID | Walmart Inc. | 2df52d35-dbb6-1d35-e063-6394a90ae110 | 2026-02-27 | Warnings, Adverse reactions | M006 |
| Quick Action | SALICYLIC ACID | Walmart Inc. | 00025ea5-d15f-49d2-a52a-6c1bd8c6a033 | 2026-02-27 | Warnings, Adverse reactions | M006 |
| Oil Free Acne Wash | SALICYLIC ACID 2% | Walmart Inc. | 31e49de0-0806-d18b-e063-6294a90ae47d | 2026-02-27 | Warnings, Adverse reactions | M006 |
| ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION | SALICYLIC ACID | CLINIQUE LABORATORIES LLC | c09ee4f6-b8f9-4d20-982a-fb490830bd34 | 2026-02-26 | Warnings | M006 |
| Acne Treatment | BENZOYL PEROXIDE | The Kroger Co. | a6526d73-4094-45b7-97f0-561dd10d61e2 | 2026-02-26 | Warnings, Adverse reactions | M006 |
| Oil Free Acne Wash | SALICYLIC ACID 2% | Meijer, Inc. | 29a62723-a58d-4912-bdab-b2fa1fac27b4 | 2026-02-24 | Warnings, Adverse reactions | M006 |
| Medicated Apricot Scrub | SALICYLIC ACID | Meijer, Inc. | 3aeb4f0b-a8f7-4ed7-b320-45e5ba0c8175 | 2026-02-19 | Warnings, Adverse reactions | M006 |
| Acne Cleanser | BENZOYL PEROXIDE | Meijer, Inc. | 932ee049-ab3d-4839-a655-772e5594f6e1 | 2026-02-19 | Warnings, Adverse reactions | M006 |
| PHARMA CLEAR SPOT TREATMENT | SALICYLIC ACID | PHARMAGEL INTERNATIONAL INC | 24736409-b500-4aae-857e-1f4fb1760a15 | 2026-02-19 | Warnings | M006 |
| Acne Scrub | SALICYLIC ACID | United Natural Foods, Inc. dba UNFI | 1a4df18d-8128-4846-80bc-262ba1a2aeca | 2026-02-17 | Warnings, Adverse reactions | M006 |
| Oil Free Acne Wash | SALICYLIC ACID 2% | United Natural Foods, Inc. dba UNFI | c489c818-d69a-4011-9c37-60c8c5b9522a | 2026-02-17 | Warnings, Adverse reactions | M006 |
| Medicated Apricot Scrub | SALICYLIC ACID | United Natural Foods, Inc. dba UNFI | 677c19eb-780b-479b-ab1d-df249e0af6ea | 2026-02-16 | Warnings, Adverse reactions | M006 |
| PoreFect | SALICYLIC ACID | Our-Science Inc. | 4afe4115-cdf0-6dd3-e063-6394a90a2453 | 2026-02-16 | Warnings | M006 |
| iShancare Folliculitis Cream | FOLLICULITIS CREAM | Shenzhen Ishan Technology Co., Ltd | 0c85c8e9-f50f-1b72-e063-6394a90a88c4 | 2026-02-13 | Warnings | M006 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2738813 | azelaic acid 14 % Topical Cream | PSN | 4ccaa734-83be-611b-e063-6294a90ab3bf | 1 |
| 2738813 | azelaic acid 140 MG/ML Topical Cream | SCD | 4ccaa734-83be-611b-e063-6294a90ab3bf | 1 |
| 2738813 | azelaic acid 14 % Topical Cream | SY | 4ccaa734-83be-611b-e063-6294a90ab3bf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84753-056-01 | 84753005601 | 30 g in 1 BOTTLE (84753-056-01) | 30 g | 2026-03-12 | No | No | Current |