Childrens Benadryl ALLERGY
- Product NDC
- 50580-534
- 11-digit product format
- 505800534
- Labeler code
- 50580
- Product ID
- 50580-534_35026484-5305-5f3d-e063-6294a90a5a50
- 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
- 2008-07-01
- 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
- Childrens 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-534-04 | Childrens Benadryl ALLERGY | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
| 50580-534-04 | Childrens Benadryl ALLERGY | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 13 |
| 50580-534-08 | Childrens Benadryl ALLERGY | 236 mL in 1 BOTTLE | SOLUTION | 236 | | 13 |
| 50580-534-08 | Childrens Benadryl ALLERGY | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
| 50580-534-16 | Childrens Benadryl ALLERGY | 2 in 1 PACKAGE | SOLUTION | 2 | | 13 |
| 50580-534-16 | Childrens Benadryl ALLERGY | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
| 50580-534-18 | Childrens Benadryl ALLERGY | 2 in 1 PACKAGE | SOLUTION | 2 | | 13 |
| 50580-534-18 | Childrens Benadryl ALLERGY | 1 in 1 CARTON | SOLUTION | 1 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Diphenhydramine hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| ammonium glycyrrhizate | INACTIVE INGREDIENT | 3VRD35U26C | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| D&C red no. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| poloxamer 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-534 | CHILDRENS BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 13 | Current NDC, Legacy NDC, 8 package rows | 20250515_fc9181b9-c92d-493e-8d7c-4a4239c6c092.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 |
|---|
| 50580-534-04 | 50580053404 | 1 BOTTLE in 1 CARTON (50580-534-04) / 118 mL in 1 BOTTLE | 1 bottle | 2008-07-01 | 0000-00-00 | No | No | Current |
| 50580-534-08 | 50580053408 | 1 BOTTLE in 1 CARTON (50580-534-08) / 236 mL in 1 BOTTLE | 1 bottle | 2008-07-01 | 0000-00-00 | No | No | Current |
| 50580-534-16 | 50580053416 | 2 CARTON in 1 PACKAGE (50580-534-16) > 1 BOTTLE in 1 CARTON > 236 mL in 1 BOTTLE | 2 carton | 2009-01-28 | 0000-00-00 | No | No | Current |
| 50580-534-18 | 50580053418 | 2 CARTON in 1 PACKAGE (50580-534-18) / 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE | 2 carton | 2021-04-12 | 0000-00-00 | No | No | Current |