Diphenhydramine Hydrochloride
- Product NDC
- 57344-091
- 11-digit product format
- 573440091
- Labeler code
- 57344
- Product ID
- 57344-091_284d2782-2253-c0b9-e063-6394a90aaeb3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA Pharmaceutical, Inc.
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-10-05
- 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
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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40 |
| Rxcui | 1049630 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57344-091-03 | Diphenhydramine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | | 4 |
| 57344-091-03 | Diphenhydramine Hydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57344-091 | DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241204_c280cf02-ebb2-4847-a66d-d02aff3ea0c9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57344-091-03 | 57344009103 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-091-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2018-10-05 | 0000-00-00 | No | No | Current |