diphenhydramine hydrochloride
- Product NDC
- 51662-1674
- 11-digit product format
- 516621674
- Labeler code
- 51662
- Product ID
- 51662-1674_4e5741df-24d9-1cab-e063-6294a90a2534
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-01-01
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- diphenhydramine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44217a8c-7656-a0f6-e063-6294a90af2ad | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51662-1674-1 | diphenhydramine hydrochloride | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 3 |
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 |
|---|---|---|---|---|---|---|
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | bdc15c6f-73b4-488e-9134-e70565df71bb | 2026-01-14 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCL 50 MG | DIPHENHYDRAMINE HCL | YYBA Corporation | 4b012549-3958-43c1-9de7-897c5d8b20d3 | 2026-01-14 | Warnings | M012 |
| Rite Aid Pharmacy congestion relief vaporizing steam | VAPORIZING STEAM | Rite Aid Pharmacy | 0fb86b23-0313-8fd8-e063-6394a90a0f5f | 2026-01-14 | Warnings | M012 |
| Vapo Steam | VAPO STEAM | TOPCO ASSOCIATES, LLC | f216f69f-9580-25ac-e053-2995a90a5ac6 | 2026-01-14 | Warnings | M012 |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | M012 |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e608643-1a74-b474-e063-6294a90ad2e0 | 2026-01-13 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | 4260542e-0980-4b0b-8177-1c9f2c53b5a6 | 2026-01-13 | Warnings | M012 |
| Sweet Comfort | MENTHOL | Saje Natural Business Inc. | cf13cccd-723d-4d61-8a5e-b36281605cc7 | 2026-01-13 | Warnings | M012 |
| Fortify | MENTHOL | Saje Natural Business Inc. | 0320a305-99d1-4909-94cc-cd6509ecb948 | 2026-01-13 | Warnings | M012 |
| Rolling Farmacy | MENTHOL | Saje Natural Business Inc. | a38765a9-22cd-4fc5-b5ab-c3cacbd52c74 | 2026-01-13 | Warnings | M012 |
| Home Farmacy | MENTHOL | Saje Natural Business Inc. | add35d10-b27a-4ae8-b2de-8a285aaef155 | 2026-01-13 | Warnings | M012 |
| Traveling Farmacy | MENTHOL | Saje Natural Business Inc. | 5b70f5aa-ed36-65ab-e053-2a91aa0a6777 | 2026-01-13 | Warnings | M012 |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | M012 |
| Chest Comfort | MENTHOL | Saje Natural Business Inc. | 8a3db169-6dd7-4dfd-8360-90315288f21b | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | H E B | c9e977b6-fba6-49ea-9d80-b43b0842bbe1 | 2026-01-12 | Warnings | M012 |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | 3f44cff6-240a-4a8d-aaa1-0da75a31a47b | 2026-01-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 44217a8c-7656-a0f6-e063-6294a90af2ad | 3 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 44217a8c-7656-a0f6-e063-6294a90af2ad | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 51662-1674-1 | 51662167401 | 1 TABLET, FILM COATED in 1 PACKET (51662-1674-1) | 2012-01-01 | No | No | Current |