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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 2026-03-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Famora Inc. | 5a7bf4cd-1d44-424d-9ef4-d484e626e326 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Menthol Cough Drops | MENTHOL | Harris Teeter | 4d502c1f-7307-ac50-e063-6294a90a6ff4 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Cherry Cough Drops | MENTHOL | Harris Teeter | 4d50cc62-c84f-0761-e063-6394a90af54a | 2026-03-18 | Warnings | M012 |
| Harris Teeter Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d516fce-d219-eee9-e063-6294a90ac59a | 2026-03-18 | Warnings | M012 |
| Harris Teeter SF Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d524b45-260e-7411-e063-6294a90af639 | 2026-03-18 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 9a77465c-6d3a-4399-9734-ad22e4b435db | 2026-03-18 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Preferred Pharmaceuticals Inc. | a56d2fe4-5bea-4668-8e66-5a6f4279d461 | 2026-03-18 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 4136e5f4-cc00-46d6-aa7f-ef56d087d7ec | 2026-03-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f9a0fb35-46d6-434f-8f9a-425a4bf50e84 | 2026-03-18 | Warnings | M012 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Grocery Outlet | 7398a372-7679-423b-a3ca-8da905a979dd | 2026-03-17 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Grocery Outlet | 0661ddeb-6289-471e-af89-7f4b7452c355 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Cough Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS | 2cf361eb-6055-2364-e063-6294a90a69a1 | 2026-03-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | b024ab38-e5da-4f5a-888f-e2a281578290 | 2026-03-16 | Warnings | M012 |
| good neighbor pharmacy night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 41f87d59-3245-46dc-88a8-b947675a90fc | 2026-03-16 | Warnings | M012 |
| Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | CVS | 2bc3eae8-ffe6-bc96-e063-6394a90a2283 | 2026-03-16 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 48438525-e49f-9303-e063-6394a90a44f2 | 2026-03-16 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, GUAIFENESIN | CVS HEALTH CORP | 4985c332-6602-fd2d-e063-6394a90accd2 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu and Nighttime Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 4981bbcd-7178-335f-e063-6394a90ae961 | 2026-03-16 | 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 |