Sleep
- Product NDC
- 57243-189
- 11-digit product format
- 572430189
- Labeler code
- 57243
- Product ID
- 57243-189_ac0a5935-31a8-4bba-af05-3f7b8bf8eef9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Salado Sales, Inc.
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1990-04-10
- 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
- Sleep
- 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 |
|---|
| 57243-189-21 | Sleep | 2 in 1 CARTON | TABLET | 2 | | 17 |
| 57243-189-21 | Sleep | 8 in 1 BLISTER PACK | TABLET | 8 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57243-189 | SLEEP (DIPHENHYDRAMINE HCL) TABLET [SALADO SALES, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240825_837c02dd-971b-4451-98d8-9c438c9db696.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 |
|---|
| 57243-189-21 | 57243018921 | 2 BLISTER PACK in 1 CARTON (57243-189-21) / 8 TABLET in 1 BLISTER PACK | 2 blister pack | 1990-04-10 | 0000-00-00 | No | No | Current |