DIPHENHYDRAMINE HYDROCHLORIDE
- Product NDC
- 53345-005
- 11-digit product format
- 533450005
- Labeler code
- 53345
- Product ID
- 53345-005_2752e252-dcaf-d8e5-e063-6394a90a2a4a
- 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
- 50 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIPHENHYDRAMINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1020477 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-005-01 | DIPHENHYDRAMINE HYDROCHLORIDE | 12000 in 1 BAG | CAPSULE, LIQUID FILLED | 12000 | | 10 |
| 53345-005-01 | DIPHENHYDRAMINE HYDROCHLORIDE | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 10 |
| 53345-005-02 | DIPHENHYDRAMINE HYDROCHLORIDE | 32 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 32 | | 10 |
| 53345-005-02 | DIPHENHYDRAMINE HYDROCHLORIDE | 80 in 1 BOX | CAPSULE, LIQUID FILLED | 80 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-005 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241123_f8de6605-4a0a-492d-beb5-f414ce8bfb0e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53345-005-01 | 53345000501 | 1 BAG in 1 BOX (53345-005-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-04-15 | 0000-00-00 | No | No | Current |
| 53345-005-02 | 53345000502 | 80 BOTTLE, PLASTIC in 1 BOX (53345-005-02) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | | 2013-04-15 | 0000-00-00 | No | No | Current |