Topcare pain relief PM
- Product NDC
- 36800-437
- 11-digit product format
- 368000437
- Labeler code
- 36800
- Product ID
- 36800-437_d589a259-1459-489c-ac04-2cd702409279
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 1992-07-21
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 36800-437-71 | Topcare pain relief PMextra strength non habit forming | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
| 36800-437-71 | Topcare pain relief PMextra strength non habit forming | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 10 |
| 36800-437-78 | Topcare pain relief PMextra strength non habit forming | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 36800-437-78 | Topcare pain relief PMextra strength non habit forming | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-437 | TOPCARE PAIN RELIEF PM EXTRA STRENGTH NON HABIT FORMING (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 10 | Legacy NDC, 4 package rows | 20241217_4923b51c-a5b6-40ed-a0bd-fc29cdf68224.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 |
|---|
| 36800-437-71 | 36800043771 | 1 BOTTLE in 1 CARTON (36800-437-71) > 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1992-07-21 | 0000-00-00 | No | No | Current |
| 36800-437-78 | 36800043778 | 1 BOTTLE in 1 CARTON (36800-437-78) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1992-07-21 | 0000-00-00 | No | No | Current |