Pain, Headache and Congestion
- Product NDC
- 51316-809
- 11-digit product format
- 513160809
- Labeler code
- 51316
- Product ID
- 51316-809_1d247756-17b5-4a31-83ad-40c0700cd1c7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-29
- Substance
- ACETAMINOPHEN; GUAIFENESIN
- Active strength
- 325; 200 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-809-09 | 51316080909 | 2 BLISTER PACK in 1 CARTON (51316-809-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2026-04-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| CVS 44-804 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc. | 2026-04-28 | HUMAN OTC DRUG LABEL | 4 |