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 |
|---|---|---|---|---|---|---|
| Basic Care Honey Lemon Cough Drops | MENTHOL | Amazon.com | c0937b13-f679-a764-e053-2a95a90abf89 | 2025-12-05 | Warnings | M012 |
| Basic Care SF Menthol Cough Drops | MENTHOL | Amazon.com | c0946295-7cf0-1bd8-e053-2a95a90af5af | 2025-12-05 | Warnings | M012 |
| Basic Care SF Honey Lemon Cough Drops | MENTHOL | Amazon.com | cf82fb0b-1b4d-def1-e053-2995a90a6fd9 | 2025-12-05 | Warnings | M012 |
| G-DOLOGEN | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Kramer Novis | 7a4e1d64-2510-405f-a1dc-e02a803b6fbd | 2025-12-05 | Warnings | M012 |
| Quality Choice Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | Chain Drug Manufacturing Assn | ce658dd5-b683-436e-b16b-0c06f6f87fd9 | 2025-12-04 | Warnings | M012 |
| Quality Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a87ba15f-b5a9-4983-a721-ca7f705aea86 | 2025-12-04 | Warnings | M012 |
| Quality Choice | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a12e2e66-d2f3-47a6-a915-a309ae828d27 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus Relief Chest Congestion | GUAIFENESIN | Chain Drug Manufacturing Assn | 034d39c0-9aad-4dff-a158-a041b9f0504f | 2025-12-04 | Warnings | M012 |
| Quality Choice | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | d01b8fb6-1ddf-4901-bda6-ae608e94a6a4 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Manufacturing Assn | 06822a28-3f82-471d-8db5-c5981b263a03 | 2025-12-04 | Warnings | M012 |
| QUALITY CHOICE | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 14596551-dd82-46b3-8eb8-e69efaea105b | 2025-12-04 | Warnings | M012 |
| Daytime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | fd5c20ed-5520-4db0-bfd4-995f043af2a4 | 2025-12-04 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 89c165ba-3ad5-49b5-a5bb-423dc8e15bad | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a2b30c27-b836-f09f-e053-2995a90ac383 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | a37c9d9d-52db-23ff-e053-2995a90a8f76 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a68df74d-dd26-3ae9-e053-2995a90a08d6 | 2025-12-04 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 55662ada-677e-4048-9529-5bca44076316 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | b13d5132-cb91-3cf6-e053-2a95a90aa47c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | 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 |