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 |
|---|---|---|---|---|---|---|
| ORIGINAL Nasal PUMP MIST No Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | ac27fd75-4fe4-433c-a434-2dac16c895c7 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WINCO FOODS, LLC | a1367804-37c9-4906-858f-8feeb748d8d3 | 2026-08-07 | Warnings | M012 |
| Severe Congestion Nasal Anti-Drip Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | a09c2d02-334a-4840-b2d0-327121cec994 | 2026-08-07 | Warnings | M012 |
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| NICOTINE GUM | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 4e88dab4-8e13-f074-e063-6394a90a3908 | 2026-08-06 | Warnings | M012 |
| Oneoo Nicotine Gum (Mint) | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 54b1329b-b422-29a5-e063-6294a90a8780 | 2026-08-06 | Warnings | M012 |
| Sine Aid PEAK MISERY | OXYMETAZOLINE HYDROCHLORIDE | Infirst Healthcare Inc. | 586a2a14-7048-0c8b-e063-6394a90a65b7 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| TOPCARE DAY TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | d1b89d17-b3b9-4133-88a3-8cd7c4efafa9 | 2026-08-05 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 507284c3-cad9-d65c-e063-6394a90a58a8 | 2026-08-05 | Warnings | M012 |
| cough and cold relief HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | United Natural Foods, Inc. dba UNFI | 90482e7a-d7c7-4127-972d-5ee55e55ed1c | 2026-08-04 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Better Living Brands, LLC | 33f34aa2-3b37-4e51-8428-4a12708aa064 | 2026-08-04 | 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 |