Mucinex D
- Product NDC
- 63824-041
- 11-digit product format
- 638240041
- Labeler code
- 63824
- Product ID
- 63824-041_302b8792-38f6-a209-e063-6294a90af24f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RB Health (US) LLC
- Application
- NDA021585
- Marketing category
- NDA
- Marketing start
- 2012-06-26
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 1200; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mucinex D
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1244675 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63824-041-12 | Mucinex DMaximum Strength | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 12 |
| 63824-041-12 | Mucinex DMaximum Strength | 12 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 12 | | 12 |
| 63824-041-24 | Mucinex DMaximum Strength | 12 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 12 | | 12 |
| 63824-041-24 | Mucinex DMaximum Strength | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 12 |
| 63824-041-36 | Mucinex DMaximum Strength | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 12 |
| 63824-041-36 | Mucinex DMaximum Strength | 12 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 12 | | 12 |
| 63824-041-71 | Mucinex DMaximum Strength | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 12 |
| 63824-041-71 | Mucinex DMaximum Strength | 24 in 1 CARTON | TABLET, EXTENDED RELEASE | 24 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| Pseudoephedrine Hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| Pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| carbomer homopolymer type B (allyl pentaerythritol crosslinked) | INACTIVE INGREDIENT | HHT01ZNK31 | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| FD&C yellow NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63824-041 | MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC] | 11 | Current NDC, Legacy NDC, 8 package rows | 20250315_d9264518-2f2c-498f-b733-6f3397336a01.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 |
|---|
| 63824-041-12 | 63824004112 | 1 BLISTER PACK in 1 CARTON (63824-041-12) > 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2020-01-01 | 0000-00-00 | No | No | Current |
| 63824-041-24 | 63824004124 | 2 BLISTER PACK in 1 CARTON (63824-041-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2012-06-26 | 0000-00-00 | No | No | Current |
| 63824-041-36 | 63824004136 | 3 in 1 CARTON | | | | | | Historical |
| 63824-041-71 | 63824004171 | 1 in 1 POUCH | | | | | | Historical |