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 |
|---|---|---|---|---|---|---|
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | f1a4ee57-33a3-4791-a769-b208b38acb72 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY Childrens Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | c499574c-f32b-4608-bf8b-51ad44e35725 | 2026-07-13 | Warnings | M012 |
| Good NeighborChildrens Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | f442c61b-7d2c-401c-b862-acbe2282927b | 2026-07-13 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 5683b099-f029-2d08-e063-6394a90ad482 | 2026-07-13 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f673cdeb-4f8b-46b4-be92-c725d74abc55 | 2026-07-13 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | e4fca5ba-2d45-4c38-b0fd-297159d1705a | 2026-07-13 | Warnings | M012 |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | AMERISOURCE BERGEN | 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 | 2026-07-13 | Warnings | M012 |
| Propolis Cooling Relief Cherry Cough Drops | MENTHOL, UNSPECIFIED FORM | Beekeeper's Naturals USA Inc | 7087566d-f24a-4508-aa25-7f42d055c43e | 2026-07-13 | Warnings | M012 |
| Sinus Pressure and Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Rite Aid Corporation | 35bcf263-3296-4d9c-84c0-146a173d6e87 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Childrens Cough Relief Cherry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | a8e2fd43-b801-41ae-8d79-8ecf4a771543 | 2026-07-13 | Warnings | M012 |
| Good Neighbor No Drip Nasal Mist Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | 7872aadd-b23c-431f-8048-24eece25ca2d | 2026-07-13 | Warnings | M012 |
| Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | 404a3521-8340-4476-a068-0e69cd0e514f | 2026-07-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Long Acting Cough Adult Tussin | DEXTROMETHORPHAN HBR | AMERISOURCE BERGEN | df3c76bd-bd5b-42d7-a5f1-560fd3cba646 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Adult Tussin Mucus and chest congestion | GUAIFENESIN | AMERISOURCE BERGEN | 97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | a217ca8a-1c00-4816-bc26-cc0f71c80c90 | 2026-07-13 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 2026-07-10 | Warnings | M012 |
| COUGH DROPS- menthol granule | MENTHOL GRANULE | Anhui Jiuhe Health Industry Co., Ltd | 5351b943-5830-e4e7-e063-6394a90a5b66 | 2026-07-10 | Warnings | M012 |
| ValuMeds Nasal Decongestant PE Phenylephrine | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 3f284420-87c1-4c17-99e5-bc569bf9d45f | 2026-07-10 | Warnings | M012 |
| Severe Congestion and Cough Multi-Symptom Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 2026-07-10 | 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 |