Childrens Benadryl Allergy Plus Congestion
- Product NDC
- 50580-341
- 11-digit product format
- 505800341
- Labeler code
- 50580
- Product ID
- 50580-341_21e89245-b2fa-5dd2-e063-6294a90a7795
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine hydrochloride and Phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-09-30
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 12.5; 5 mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Childrens Benadryl Allergy Plus Congestion
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b8b75904-3806-4258-89c1-d6ff486ed41c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50580-341-01 | 2024-02-01 | C162847 | 48780-1 | 1030e365-5619-111a-e063-dadaa90a10e2 | Childrens Benadryl Allergy Plus Congestion |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-341-01 | Childrens Benadryl Allergy Plus Congestion | 1 in 1 CARTON | SOLUTION | 1 | 9 | |
| 50580-341-01 | Childrens Benadryl Allergy Plus Congestion | 118 mL in 1 BOTTLE | SOLUTION | 118 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-341-01 | ML - Milliliter | 50580-341 | 3a3a40d6-6d24-483d-80b8-2701a3da572e | 1 | 2020-09-14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-341 | CHILDRENS BENADRYL ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241109_b8b75904-3806-4258-89c1-d6ff486ed41c.zip |
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 |
|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 2024-11-21 | Warnings | M012 |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 028b025e-2dde-4bef-ba7b-61774e855b4b | 2024-11-21 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | 856cb3c3-8f32-4285-8c13-25f01779a31a | 2024-11-21 | Warnings | M012 |
| Night Time Severe Cold and Flu Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 3375a059-2939-438e-92b5-a7f1952bbb22 | 2024-11-21 | Warnings | M012 |
| NiteTime Cold/Flu, Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 9033bf94-f444-4488-b717-050d04dee388 | 2024-11-21 | Warnings | M012 |
| Day and Night Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 4b554ce8-9a6a-444f-b5ea-63359bbc0653 | 2024-11-21 | Warnings | M012 |
| Day Severe Cold and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores, Inc. | 7492b381-9eca-4b07-b356-63fdaea14f81 | 2024-11-21 | Warnings | M012 |
| Severe sinus Congestion Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | e173bec9-14df-4535-a023-47d8cda8d4ec | 2024-11-21 | Warnings | M012 |
| COLD FLU and SORE THROAT RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 1161e5dc-0677-4fb9-964f-971a508098b6 | 2024-11-21 | Warnings | M012 |
| Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services, LLC | fc8c70d6-6be5-4f12-84b0-125fc82149ec | 2024-11-21 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | WinCo Foods LLC | b3b6065a-56da-45e9-b89d-f6553bc181c9 | 2024-11-21 | Warnings | M012 |
| Family Wellness Oxymetazoline Sinus Severe | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 13237d31-c60a-49f8-9b96-4414cf766a08 | 2024-11-21 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5b55d1df-275b-40d8-bde3-fc43313b7eb3 | 2024-11-20 | Warnings | M012 |
| Halls Green Apple | MENTHOL | Mondelez Global LLC | 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2 | 2024-11-20 | Warnings | M012 |
| Halls Blueberry | MENTHOL | Mondelez Global LLC | 275a6935-ea44-486e-e063-6394a90ae19a | 2024-11-20 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 234bd567-4e3c-419f-a000-fdfc28cafc8b | 2024-11-20 | Warnings | M012 |
| NICE Assorted Cough Drops | MENTHOL | Leosons Overseas Corp | 96db0f37-41cc-1ebd-e053-2a95a90a3215 | 2024-11-19 | Warnings | M012 |
| Nice Cherry Cough Drops | MENTHOL | Leosons Overseas Corp | 98e52604-6e41-6408-e053-2995a90a6bc8 | 2024-11-19 | Warnings | M012 |
| NICE Citrus Cough Drops | MENTHOL | Leosons Overseas Corp | 96d9527d-9bf9-ce82-e053-2995a90aff0c | 2024-11-19 | Warnings | M012 |
| NICE Menthol Cough Drops | MENTHOL | Leosons Overseas Corp | 96d77897-475c-482c-e053-2995a90a2da4 | 2024-11-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086723 | Benadryl-D Children's Allergy & Sinus 12.5 MG / 5 MG in 5 mL Oral Solution | PSN | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086720 | diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution | PSN | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086723 | diphenhydramine hydrochloride 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution [Benadryl-D Allergy and Sinus] | SBD | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086720 | diphenhydramine hydrochloride 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086723 | Benadryl Children's Allergy Plus Congestion 12.5 MG / 5 MG per 5 ML Oral Solution | SY | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086723 | Benadryl-D Allergy and Sinus (diphenhydramine hydrochloride 12.5 MG/ML / phenylephrine hydrochloride 5 MG) per 5 ML Oral Solution | SY | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
| 1086720 | diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | b8b75904-3806-4258-89c1-d6ff486ed41c | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-341-01 | 50580034101 | 1 BOTTLE in 1 CARTON (50580-341-01) / 118 mL in 1 BOTTLE | 1 bottle | 2014-09-30 | 0000-00-00 | No | No | Current |