Puregen Labs Allergy Relief
- Product NDC
- 80513-201
- 11-digit product format
- 805130201
- Labeler code
- 80513
- Product ID
- 80513-201_4745d501-fbad-b33f-e063-6294a90a0753
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-01
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Puregen Labs Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049906 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80513-201-16 | Puregen Labs Allergy Relief | 473 mL in 1 BOTTLE | LIQUID | 473 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80513-201-16 | 80513020116 | 473 mL in 1 BOTTLE (80513-201-16) | 473 ml | 2024-12-01 | No | No | Current |