Childrens Benadryl Allergy Plus Congestion
- Product NDC
- 50580-341
- Requested package NDC
- 50580-341-01
- 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
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 |
|---|---|---|---|---|---|---|
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Geiss, Destin & Dunn Inc. | 1ea07a01-8779-48c2-a287-b7be866cce7b | 2026-09-10 | Warnings | M012 |
| Childrens Cold and Allergy Relief | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | d64fe757-9948-4727-b5dd-1f8e4e4763e2 | 2026-09-10 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | M012 |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | M012 |
| DRx Choice Fruit Punch | GUAIFENESIN | Raritan Pharmaceuticals Inc | a19d7e1c-c04e-41c6-8af6-ecde96299216 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | M012 |
| MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 3856c1e4-814f-85c4-e063-6394a90ab8a8 | 2026-09-09 | Warnings | M012 |
| DRx Choice Long Acting Cough | DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | 875b40bd-7955-4048-abbf-7f43d9ea3ac5 | 2026-09-09 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 4b8ae971-ab57-4937-a878-72d905d7b849 | 2026-09-09 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 82ba9a73-60ef-49fd-960f-5ca2bb79555e | 2026-09-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | The Kroger Co. | 49829083-5c0a-4620-bfb3-7103642368db | 2026-09-09 | Warnings | M012 |
| DRx Choice Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS | 7a3bb739-ff50-4d29-b270-d6b084906493 | 2026-09-09 | Warnings | M012 |
| DRx Choice Children daytime Cough and Chest Congestion | DEXTROMETHORPHAN HBR AND GUAIFENESIN | RARITAN PHARMACEUTICALS | 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9 | 2026-09-09 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 8a166067-b492-4742-b74c-28fac87c8d70 | 2026-09-09 | Warnings | M012 |
| DRx Choice maximum strength Severe Cough plus sore throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | a096cb76-0d1c-4ca8-854a-5199da0bc8f7 | 2026-09-09 | Warnings | M012 |
| Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | efb69cc1-a745-6efc-e053-2a95a90abdc9 | 2026-09-08 | Warnings | M012 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | efb5f0b9-9825-ab23-e053-2995a90a26ab | 2026-09-08 | Warnings | M012 |
| Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | f4328b44-cdfa-41aa-e053-2995a90a2728 | 2026-09-08 | Warnings | M012 |
| Vicks childrens Cough Congestion | PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | The Procter & Gamble Manufacturing Company | e2356457-9791-3710-e053-2995a90ad140 | 2026-09-08 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 077fac1a-0ec5-40d9-8861-a281b48f650a | 2026-09-08 | 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 |