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 |
|---|---|---|---|---|---|---|
| Extra Strength Itch Stopping | ITCH STOPPING CREAM | Universal Distribution Centre LLC | b9a42aa3-1903-76f0-e053-2a95a90a51d1 | 2024-05-13 | Warnings | TC2D6JAD40 |
| Enviroclenz | BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM | Deseret Biologicals, Inc. | 92816bbe-96d6-45fc-9929-d3e6df394a33 | 2024-05-02 | Warnings | 6DC9Q167V3 |
| childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreen Company | 7848bb09-2af8-47f6-b32d-96635a750a55 | 2024-04-29 | Warnings | 1049906 TC2D6JAD40 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Haleon US Holdings LLC | 7decc168-e847-4bbe-910b-26081469406f | 2024-04-26 | Warnings | TC2D6JAD40 |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Dye Free Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | f1a33c2f-2330-43f3-8026-de21808aec66 | 2024-04-22 | Warnings | 1049906 TC2D6JAD40 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 29b49616-ee5a-4574-81f1-0052addb8f66 | 2024-04-22 | Warnings | TC2D6JAD40 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | b8757d18-6c7d-45de-925a-e2814625f749 | 2024-04-22 | Warnings | TC2D6JAD40 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c573da1e-c7ca-46e6-ad42-4ded2547afc3 | 2024-04-22 | Warnings | 1049906 TC2D6JAD40 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 47660794-22cc-4863-a183-e694d27e3543 | 2024-04-19 | Warnings | TC2D6JAD40 |
| EZ Nite Sleep | DIPHENHYRAMINE HYDROCHLORIDE | KROGER COMPANY | 0fec16a4-b4eb-8f8f-e063-6394a90a7327 | 2024-04-17 | Warnings | TC2D6JAD40 |
| Dimetapp Cough and Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 15b0f5ff-202a-d19f-e063-6394a90af2b8 | 2024-04-15 | Warnings | TC2D6JAD40 |
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | TC2D6JAD40 |
| Childrens Dye Free Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 1c4d09ed-4e0f-430d-b17f-6a23f996a55d | 2024-04-15 | Warnings | 1049906 TC2D6JAD40 |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | ec691492-a295-4b48-a1a3-5824931efa97 | 2024-04-09 | Warnings, Adverse reactions | TC2D6JAD40 |
| Allergy Childrens | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | ab28cbc4-7a6f-46e9-8616-be78e8cb24fe | 2024-04-08 | Warnings | 1049906 TC2D6JAD40 |
| Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 89360fa8-014d-4da8-bb1c-197e3aa52256 | 2024-04-06 | Warnings | TC2D6JAD40 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 6fe6fe2d-4405-4e7a-a2ed-5eb367d52842 | 2024-04-05 | Warnings, Adverse reactions | 1049906 TC2D6JAD40 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.