BENADRYL Allergy
- Product NDC
- 50580-573
- 11-digit product format
- 505800573
- Labeler code
- 50580
- Product ID
- 50580-573_2cc68544-e514-f895-e063-6394a90aa577
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-02
- 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
- BENADRYL Allergy
- 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, 1049908 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-573-04 | BENADRYL Allergy | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 50580-573-04 | BENADRYL Allergy | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-573 | BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 3 | Current NDC, 2 package rows | 20250131_224ba2a3-1a93-29c8-e063-6394a90a9bef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-573-04 | 50580057304 | 1 BOTTLE in 1 CARTON (50580-573-04) / 118 mL in 1 BOTTLE | 1 bottle | 2024-12-02 | No | No | Historical |