MEDPURA Benzoyl Peroxide
- Product NDC
- 71399-9478
- 11-digit product format
- 713999478
- Labeler code
- 71399
- Product ID
- 71399-9478_4911da35-ce19-18af-e063-6394a90a5554
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzoyl Peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Akron Pharma Inc.
- Application
- M006
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-13
- Substance
- BENZOYL PEROXIDE
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MEDPURA Benzoyl Peroxide
- Brand name suffix
- Aqueous Base, Acne Treatment Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOYL PEROXIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W9WZN9A0GM |
| Rxcui | 308694, 486131 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71399-9478-5 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 42.5 mL in 1 TUBE | GEL | 42.5 | | 4 |
| 71399-9478-5 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 1 in 1 CARTON | GEL | 1 | | 4 |
| 71399-9478-6 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 1 in 1 CARTON | GEL | 1 | | 4 |
| 71399-9478-6 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 60 mL in 1 TUBE | GEL | 60 | | 4 |
| 71399-9478-9 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 90 mL in 1 TUBE | GEL | 90 | | 4 |
| 71399-9478-9 | MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel | 1 in 1 CARTON | GEL | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71399-9478 | MEDPURA BENZOYL PEROXIDE AQUEOUS BASE, ACNE TREATMENT GEL (BENZOYL PEROXIDE) GEL [AKRON PHARMA INC.] | 3 | Current NDC, Legacy NDC, 6 package rows | 20240922_b7d335d1-3022-4b28-913c-477152a7dad2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71399-9478-5 | 71399947805 | 1 TUBE in 1 CARTON (71399-9478-5) / 42.5 mL in 1 TUBE | 1 tube | 2024-09-13 | 0000-00-00 | No | No | Current |
| 71399-9478-6 | 71399947806 | 1 TUBE in 1 CARTON (71399-9478-6) / 60 mL in 1 TUBE | 1 tube | 2024-09-13 | 0000-00-00 | No | No | Current |
| 71399-9478-9 | 71399947809 | 1 TUBE in 1 CARTON (71399-9478-9) / 90 mL in 1 TUBE | 1 tube | 2024-09-13 | | No | No | Historical |