Nighttime Sleep Aid
- Product NDC
- 67091-115
- 11-digit product format
- 670910115
- Labeler code
- 67091
- Product ID
- 67091-115_96222bb4-d747-48d5-8c2d-0b208582abd8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- WinCo Foods, LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2000-06-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nighttime Sleep Aid
- Listing expiration
- 2027-12-31
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 |
|---|
| 67091-115-10 | Nighttime Sleep Aid | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 14 |
| 67091-115-10 | Nighttime Sleep Aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WINCO FOODS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67091-115 | NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250217_f446e56f-c664-4092-8712-aa3f204172f8.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 |
|---|
| 67091-115-10 | 67091011510 | 1 BOTTLE, PLASTIC in 1 CARTON (67091-115-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2000-06-10 | 0000-00-00 | No | No | Current |