topcare sleep aid
- Product NDC
- 36800-431
- 11-digit product format
- 368000431
- Labeler code
- 36800
- Product ID
- 36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-09-11
- 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
- topcare sleep aid
- Brand name suffix
- nighttime
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-431-62 | topcare sleep aidnighttime | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 8 |
| 36800-431-62 | topcare sleep aidnighttime | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | | 8 |
| 36800-431-67 | topcare sleep aidnighttime | 24 in 1 CARTON | TABLET, FILM COATED | 24 | | 8 |
| 36800-431-67 | topcare sleep aidnighttime | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | | 8 |
| 36800-431-78 | topcare sleep aidnighttime | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 36800-431-78 | topcare sleep aidnighttime | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-431 | TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 8 | Current NDC, Legacy NDC, 6 package rows | 20240724_30284271-0411-4abf-bc62-d956dc794432.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 |
|---|
| 36800-431-62 | 36800043162 | 12 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2001-09-11 | 0000-00-00 | No | No | Current |
| 36800-431-67 | 36800043167 | 24 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2004-01-27 | 0000-00-00 | No | No | Current |
| 36800-431-78 | 36800043178 | 1 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-09-13 | 0000-00-00 | No | No | Current |