DIPHENHYDRAMINE HYDROCHLORIDE
- Product NDC
- 53345-007
- 11-digit product format
- 533450007
- Labeler code
- 53345
- Product ID
- 53345-007_2767a338-d7e3-dc51-e063-6394a90a29b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-09-15
- 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
- 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
- DIPHENHYDRAMINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 1049909 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 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 |
|---|---|---|---|---|---|---|
| 53345-007-01 | DIPHENHYDRAMINE HYDROCHLORIDE | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 4 | |
| 53345-007-01 | DIPHENHYDRAMINE HYDROCHLORIDE | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 Extra Strength | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4f33c1fb-150b-4083-a9a4-c0fbab4b6133 | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 5ca7dc60-af0c-47c6-b453-8b39c744eb5b | 2026-01-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 2ce5f2af-cabc-466f-b0c5-256e6e6d4c88 | 2026-01-27 | Warnings | M012 |
| Sinus Headache and Pain Day, Non-drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | c33340c0-47d3-45e2-997b-3d9fb148900f | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | b7501b59-d25a-49ec-9cbf-47018bce8397 | 2026-01-27 | Warnings | M012 |
| good sense nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | f90bd64a-dd1a-4319-87cd-427d57f677ab | 2026-01-26 | Warnings | M012 |
| Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 547ff880-3d40-4a4a-84ee-cd0d5290a9b9 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Day and Night Cold and Flu | MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | WAL-MART STORES INC | d6a35fb8-1899-4da2-ad2b-0423e332845d | 2026-01-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Prodose, Inc. | 7e5de5b0-18f0-4807-8686-da9821f918ce | 2026-01-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | b9fbf917-12b7-770f-e053-2995a90afe93 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b58b2c36-a403-4dae-b3b2-f0ffd28a963b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 870e6bcb-84ab-45e0-ae57-08a9a182eb0b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | eb8e83a4-981b-48a5-88f4-3a0ba358d3bc | 2026-01-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 8d2d765f-a7e3-40e6-b35d-0e8806a7ea59 | 2026-01-26 | Warnings | M012 |
| NIGHTTIME COLD AND FLU CHERRY | PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Walgreen Company | 02a6781c-aa6f-8fb0-e063-6294a90a043d | 2026-01-26 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE | Walgreen Company | 02e5f475-4e9f-2856-e063-6294a90a21fd | 2026-01-26 | Warnings | M012 |
| GNP Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | AmerisourceBergen | 0bcc55bf-9654-120b-e063-6394a90a59d1 | 2026-01-26 | Warnings | M012 |
| S2 | RACEPINEPHRINE HYDROCHLORIDE | Nephron Pharmaceuticals Corporation | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 2026-01-26 | Warnings | M012 |
| SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d97c634-0975-42d5-8ade-2ed2018cfe9d | 2026-01-26 | Warnings | M012 |
| GOOD SENSE NIGHT TIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | L. Perrigo Company | cd68289b-3850-40c6-9439-aae0e2d7637d | 2026-01-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 4 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-007-01 | 53345000701 | 1 BAG in 1 BOX (53345-007-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-09-15 | 0000-00-00 | No | No | Current |