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 |
|---|---|---|---|---|---|---|
| Afrin Original Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0f5ec576-f788-40aa-9088-0dd672e3cc7c | 2025-12-04 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | 432a79a9-c69d-4514-894a-7832e1b745ef | 2025-12-04 | Warnings | M012 |
| GENCONTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 69d16d25-b09b-430e-8e01-0962d840dc21 | 2025-12-04 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | H E B | 7c04ab14-af28-4598-90ef-56ac11902c7d | 2025-12-04 | Warnings | M012 |
| Desgen Pediatric | DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 2025-12-04 | Warnings | M012 |
| Presgen B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5befa829-32bd-4978-8a0e-1d6513ff37a4 | 2025-12-03 | Warnings | M012 |
| TUSSLIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kramer Novis | 987e19a5-032f-44e9-b4c7-8a764d502695 | 2025-12-03 | Warnings | M012 |
| DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 450e8974-8ff8-4b82-e063-6394a90a9366 | 2025-12-03 | Warnings | M012 |
| Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store Products, Inc. | 4510223f-1c88-2796-e063-6394a90a18ac | 2025-12-03 | Warnings | M012 |
| Carolina Crud Crusher | DEXTROMETHORPHAN HBR, GUAIFENESIN | Weeks & Leo Co., Inc. | 0b606683-7d68-cca5-e063-6394a90a6f58 | 2025-12-03 | Warnings | M012 |
| Capmist DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Capital Pharmaceutical, LLC | 63733ac3-859e-4a8e-8717-d852bd303408 | 2025-12-03 | Warnings | M012 |
| ALA-HIST IR | DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 0d203b5c-8b10-428b-8703-17be6b4ce6eb | 2025-12-03 | Warnings | M012 |
| ALAHIST DM | DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | fdaa062d-110e-798d-e053-6394a90a755c | 2025-12-03 | Warnings | M012 |
| Alahist D | PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | a1b8533a-ef8b-57cc-e053-2995a90a5d9e | 2025-12-03 | Warnings | M012 |
| Alahist PE | DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | ada2d582-5813-2029-e053-2a95a90ae567 | 2025-12-03 | Warnings | M012 |
| Benadryl Allergy Extra Strength Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 30aca3ab-b091-3939-e063-6294a90a9819 | 2025-12-03 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | L.N.K. International, Inc. | 9f2daffc-1904-4d64-9f84-689c88601e06 | 2025-12-03 | Warnings | M012 |
| Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | d291faa9-894e-421c-8115-8a8c2a937172 | 2025-12-03 | Warnings | M012 |
| SINUS PAIN AND CONGESTION | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 697dffdd-5b56-4395-8e69-6b4360d9fdc5 | 2025-12-02 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 9c8c1974-f931-4493-abb5-ecdc32764ab3 | 2025-12-02 | 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 |