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 |
|---|---|---|---|---|---|---|
| Eye Wash | WATER | Jiangxi Zhenmei Biological Technology Co.,Ltd | c68795b8-bf68-0d01-e053-2a95a90abebb | 2023-12-04 | Warnings | 059QF0KO0R |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | TC2D6JAD40 |
| Tact Cool Jelly | DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL | Sato Pharmaceutical Co., Ltd. | f34872c9-91b9-49db-8e41-5b54a069284a | 2023-12-01 | Warnings | TC2D6JAD40 |
| Banophen | DIPHENHYDRAMINE HCL | Proficient Rx LP | 62934d0f-b23d-4c03-9d60-a7bad41f9b42 | 2023-12-01 | Warnings | TC2D6JAD40 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | b1c849e5-8003-4fd3-811d-6a927523e353 | 2023-12-01 | Warnings | TC2D6JAD40 |
| Acetaminophen and Diphenhydramine hydrochloride | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Aurohealth LLC | 3ba51b52-7ae6-4335-b178-1b7b6ef36227 | 2023-11-29 | Warnings | TC2D6JAD40 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Simpex Pharma Pvt. Ltd | 82771f6a-8b3d-4ffa-8b35-09c2faf3582c | 2023-11-29 | Warnings | TC2D6JAD40 |
| Discount Drug Mart Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Discount Drug Mart | 8579df23-ac07-9df8-e053-2991aa0a8bbb | 2023-11-29 | Warnings | TC2D6JAD40 |
| Acetaminophen and Diphenhydramine hydrochloride | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Better Living Brands, LLC | fc07d516-9ffe-9989-e053-6294a90ae1a5 | 2023-11-28 | Warnings | TC2D6JAD40 |
| Phexxi | LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE | Evofem, Inc. | 173ff411-7227-47b0-94dc-844e1ebaf14e | 2023-11-21 | Warnings, Adverse reactions | 2968PHW8QP |
| RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 8badbaad-eb35-4251-a779-00474819360d | 2023-11-13 | Warnings | TC2D6JAD40 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Jones Healthcare Group - Packaging Services, Inc | ec2070df-8a8a-4cd1-8830-62655433fb3b | 2023-11-05 | Warnings | TC2D6JAD40 |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6dd6396-93e9-1096-e053-6394a90af06d | 2023-11-02 | Warnings | TC2D6JAD40 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | Warnings | TC2D6JAD40 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HYDROCHLORIDE | Natco Pharma USA LLC | 54b64354-ac10-42ff-a53d-96cef933a91a | 2023-11-01 | Warnings | 1049906 TC2D6JAD40 |
| children allergy relief dye free cherry | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 | 2023-11-01 | Warnings | 1049906 TC2D6JAD40 |
| Dr. Sheffield Anti Itch Cream | ANTI ITCH CREAM | Sheffield Pharmaceuticals LLC | 77f0593e-f694-4c02-9fd9-ad56ff2a920c | 2023-10-30 | Warnings | TC2D6JAD40 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Magno-Humphries, Inc. | 9d2275c8-0c3d-d2b3-e053-2995a90a368e | 2023-10-27 | Warnings | TC2D6JAD40 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | FRONT PHARMACEUTICAL PLC | fde2069b-344e-46da-bb95-c5113e0f35d6 | 2023-10-26 | Warnings | TC2D6JAD40 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | TC2D6JAD40 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.