Severe Sinus Congestion and Pain
- Product NDC
- 63868-071
- 11-digit product format
- 638680071
- Labeler code
- 63868
- Product ID
- 63868-071_24359114-3c39-dcb1-e063-6394a90a9d99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-11-13
- Marketing end
- 2026-12-31
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Severe Sinus Congestion and Pain
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1243679 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63868-071-24 | Severe Sinus Congestion and Pain | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | | 3 |
| 63868-071-24 | Severe Sinus Congestion and Pain | 2 in 1 CARTON | TABLET, COATED | 2 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-071 | SEVERE SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241013_1b4e87f8-3f9e-4865-9128-527d2d621593.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 |
|---|
| 63868-071-24 | 63868007124 | 2 BLISTER PACK in 1 CARTON (63868-071-24) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2009-11-13 | 2026-12-31 | No | No | Current |