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 |
|---|---|---|---|---|---|---|
| SanaTos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 1fc1408c-c540-39ab-e063-6394a90aa477 | 2024-08-15 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 489645ad-d7da-5f52-e054-00144ff8d46c | 2024-08-14 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 6c949602-e0c8-40ce-8fb3-5147f406fa04 | 2024-08-14 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 3dbdf020-ca17-1197-e054-00144ff8d46c | 2024-08-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 445e49a2-6ed0-434c-aaea-3ce14bc7df59 | 2024-08-12 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | d49b42ad-0ae0-48c9-adba-5fc2ced97764 | 2024-08-12 | Warnings | M012 |
| RYMED | DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | c1d6e914-74cc-4cdf-9587-7eaaa4a386e5 | 2024-08-12 | Warnings | M012 |
| WesTussin DM NF | WESTUSSIN DM NF | Westminster Pharmaceuticals, LLC | 4e0f9f97-a31c-41ac-9d6c-d81efd20fcef | 2024-08-08 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2f2a2864-af11-4240-bdad-a54aca58d01b | 2024-08-07 | Warnings | M012 |
| Cold plus Flu Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0199aea2-a9c1-4c9d-8786-28b9dadc832e | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 32d1ce6e-2617-4b50-a9e6-2e1941465dff | 2024-08-07 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 07362db5-a372-4463-af8b-06e8783ca865 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1fb11d90-48bf-4baa-9b3a-5d64d81e3a06 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 574774b2-9813-4799-9cd4-27e296dd8584 | 2024-08-07 | Warnings | M012 |
| Cold Max Day and NIght | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | a92bcefb-ba29-4b3f-a60b-b4476ca8cf04 | 2024-08-07 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 778f1f5a-fd04-456f-90d0-998b93e774a5 | 2024-08-07 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 990f3232-bc75-45cf-8a50-cd7861d83f98 | 2024-08-07 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 0f5f25c6-7389-4285-b8d5-463cb7b6fcc4 | 2024-08-07 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Care One (Retail Business Services, LLC.) | a9a5b39d-b4c8-414e-8fe7-4c0601f75197 | 2024-08-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | b94feeb6-f33f-410d-a9b0-776b1ccf34a9 | 2024-08-04 | 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 |