EXTRA STRENGTH PAIN RELIEF PM
- Product NDC
- 68210-4145
- 11-digit product format
- 682104145
- Labeler code
- 68210
- Product ID
- 68210-4145_ee8f02d1-fbcd-ab46-e053-2a95a90ae3ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SPIRIT PHARMACEUTICALS LLC
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2021-04-28
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-4145-2 | EXTRA STRENGTH PAIN RELIEF PM | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 68210-4145-2 | EXTRA STRENGTH PAIN RELIEF PM | 24 in 1 BOTTLE | TABLET | 24 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4145 | EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SPIRIT PHARMACEUTICALS LLC] | 5 | Legacy NDC, 2 package rows | 20241215_3a782f3a-1c84-4268-81a7-d0b999914fdd.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 |
|---|
| 68210-4145-2 | 68210414502 | 1 BOTTLE in 1 CARTON (68210-4145-2) > 24 TABLET in 1 BOTTLE | 1 bottle | 2021-04-28 | 0000-00-00 | No | No | Current |