Topcare Chest Congestion and Sinus Congestion Relief PE
- Product NDC
- 36800-989
- 11-digit product format
- 368000989
- Labeler code
- 36800
- Product ID
- 36800-989_dbeaa93d-d138-43c2-a117-9c3aafd95d3a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin/phenylephrine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-06-05
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 400; 10 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
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topcare Chest Congestion and Sinus Congestion Relief PE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 400 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1304111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-989-50 | Topcare Chest Congestion and Sinus Congestion Relief PE | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 36800-989-50 | Topcare Chest Congestion and Sinus Congestion Relief PE | 50 in 1 BOTTLE | TABLET | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-989 | TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [TOPCO ASSOCIATES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241220_b6c0362f-86ca-4f08-ba53-800c6df2c025.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 |
|---|
| 36800-989-50 | 36800098950 | 1 BOTTLE in 1 CARTON (36800-989-50) / 50 TABLET in 1 BOTTLE | 1 bottle | 2006-06-05 | 0000-00-00 | No | No | Current |