DIPHENHYDRAMINE HYDROCHLORIDE
- Product NDC
- 53345-002
- 11-digit product format
- 533450002
- Labeler code
- 53345
- Product ID
- 53345-002_27667628-c793-e83c-e063-6394a90a1d32
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-04-15
- 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 |
|---|---|
| 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 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 |
|---|---|---|---|---|---|---|
| 53345-002-02 | DIPHENHYDRAMINE HYDROCHLORIDE | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 53345-002-02 | DIPHENHYDRAMINE HYDROCHLORIDE | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 5 |
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 |
|---|---|---|---|---|---|---|
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | 16b2edd2-c16b-5713-e063-6394a90acf46 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | 08a38cd2-04ae-1ef9-e063-6294a90a8868 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | KROGER COMPANY | 0f2c1c6a-29bc-e4a8-e063-6394a90a28cb | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 35acf7d9-e567-996d-e063-6394a90a1cf6 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 048cfa3a-4519-400d-a5ab-ce05c9cc4ec8 | 2025-11-26 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fe58ce40-ae88-4dc5-9486-e67041f6d852 | 2025-11-26 | Warnings | M010 |
| nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | b72c47a3-cae3-4b98-ae85-e1313b6fd501 | 2025-11-25 | Warnings | M010 |
| Nighttime Wal Flu Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WALGREEN CO. | e88f7777-9987-4e3c-a3d5-3da60f190bfd | 2025-11-25 | Warnings | M010 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALGREENS CO | 807e8ace-2901-4c5f-96dc-04c755484b95 | 2025-11-25 | Warnings | M010 |
| Sleep | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | 837c02dd-971b-4451-98d8-9c438c9db696 | 2025-11-24 | Warnings | M010 |
| Nighttime SleepAid | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | 3802d57e-7943-c0c2-e063-6394a90a7580 | 2025-11-20 | Warnings | M010 |
| Sleep-Aid Nighttime | DIPHENHYDRAMINE HCL | CVS PHARMACY | 6bd1ad2e-8f47-412d-8620-b149ad90c292 | 2025-11-17 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | f8d50b4e-735d-4d91-a18d-be3537e46e99 | 2025-11-15 | Warnings | M010 |
| SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Company name: Topco Associates, LLC | 7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec | 2025-10-31 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | e96ec4d4-53b9-4636-a58c-1a5923a021ad | 2025-10-31 | Warnings | M010 |
| GOODNOW SLEEP AID | DIPHENHYDRAMINE HCL | Gobrands, Inc | 7d821b7d-6a31-4ff7-b587-51907ba62658 | 2025-10-29 | Warnings | M010 |
| Meijer Nighttime Sleep-aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | MEIJER DISTRIBUTION INC | c7258241-2966-4876-918b-84bbf50ec4bc | 2025-10-24 | Warnings | M010 |
| Meijer Nighttime Sleep Aid Non Habit Forming | DIPHENHYDRAMINE HYDROCHLORIDE | MEIJER DISTRIBUTION INC | fd476bfa-3e2e-470c-9180-19aa43e4af24 | 2025-10-24 | Warnings | M010 |
| Sominex | DIPHENHYDRAMINE HYDROCHLORIDE | Medtech Products Inc. | f7858ecf-8498-4465-85d8-3e7814737573 | 2025-10-23 | Warnings | M010 |
| Sominex Max | DIPHENHYDRAMINE HCL | Medtech Products Inc. | e8f6991f-c47a-4d12-934b-04fdf092dac3 | 2025-10-23 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 5 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-002-02 | 53345000202 | 1 BAG in 1 BOX (53345-002-02) / 20000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-04-15 | 0000-00-00 | No | No | Current |