NDC 57237-318-01 - Diphenhydramine HCl Oral Solution
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 57237-318
- Requested NDC
- 57237-318-01
- Package NDCs from labels
- 57237-318-01, 57237-318-11
- Manufacturer
- Rising Pharma Holdings, Inc.
- Effective date
- 2025-07-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Diphenhydramine HCl Oral Solution 25 mg/10 mL | Rising Pharma Holdings, Inc. | 2025-07-01 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-318-01 | Diphenhydramine HCl Oral Solution | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 3 | |
| 57237-318-11 | Diphenhydramine HCl Oral Solution | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-318-01 | ML - Milliliter | 57237-318 | 68c91723-6496-40f9-acb3-9533ba0ffe84 | 1 | 2024-04-05 |
| 57237-318-11 | ML - Milliliter | 57237-318 | 1e834ec8-4814-45ec-884d-f12e845892f7 | 1 | 2024-03-12 |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TopCo Associates LLC | 53b15e75-9efd-4b4b-834b-6e9f12c60108 | 2024-12-02 | Warnings | TC2D6JAD40 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f4468840-e17c-6888-e053-2995a90a04a0 | 2024-12-02 | Warnings | TC2D6JAD40 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc. | 6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f | 2024-12-02 | Warnings | TC2D6JAD40 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | CVS Pharmacy, Inc. | 6dd802ec-fc26-3913-e053-2a91aa0ad05d | 2024-12-02 | Warnings | TC2D6JAD40 |
| Extra Strength Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | INGLES MARKETS, INC. | 27fd288e-c07a-617f-e063-6394a90a17a4 | 2024-11-28 | Warnings | TC2D6JAD40 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Geri-Care Pharmaceutical Corp | ac8a14ac-7023-1e23-e053-2995a90aea3a | 2024-11-28 | Warnings | TC2D6JAD40 |
| Childrens Benadryl DYE-FREE ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 10d478ff-ddc6-45da-87ff-cfe1b2b07a8e | 2024-11-27 | Warnings | 1049906 TC2D6JAD40 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cd10af6-a2fa-44f8-8df3-a6d2a95a5293 | 2024-11-27 | Warnings | 1049906 TC2D6JAD40 |
| Benadryl Original Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 920c50cb-9bdd-4a36-bb3d-c2559db73327 | 2024-11-26 | Warnings | TC2D6JAD40 |
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% | PURIFIED WATER 98.3% | Acme United Corporation | 9248ee71-2d47-620d-e053-2995a90af5c8 | 2024-11-26 | Warnings | 059QF0KO0R |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 236ff457-0ec1-9c49-e063-6394a90a707a | 2024-11-26 | Warnings | TC2D6JAD40 |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | cca454e0-b2bd-4215-bc06-426fcc3f7bd6 | 2024-11-26 | Warnings | 059QF0KO0R |
| PhysiciansCare Ophthalmic Solution Eyewash | PURIFIED WATER 98.3% | Acme United Corporation | d3812fa3-9334-464d-b50c-98548ff76727 | 2024-11-26 | Warnings | 059QF0KO0R |
| DANGTTEOL | MINERAL WATER | AQBC CO., LTD | 27db14a9-3812-433f-e063-6394a90a11e7 | 2024-11-26 | Warnings | 059QF0KO0R |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 50d74111-6d1b-4681-a264-f7e550320259 | 2024-11-25 | Warnings | TC2D6JAD40 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | efb05387-72c0-4643-8541-b7990c202ce6 | 2024-11-25 | Warnings | TC2D6JAD40 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 508a65ee-42fa-4c0b-b24d-9faac6b0eba7 | 2024-11-24 | Warnings | TC2D6JAD40 |
| Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz | DIPHENHYDRAMINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2781fc28-8a7d-d0fa-e063-6394a90ac793 | 2024-11-22 | Warnings | TC2D6JAD40 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | de2a64ce-c169-4162-b79e-d3809bea2147 | 2024-11-22 | Warnings | TC2D6JAD40 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 2024-11-21 | Warnings | TC2D6JAD40 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.