Guiafenesin
- Product NDC
- 11534-164
- 11-digit product format
- 115340164
- Labeler code
- 11534
- Product ID
- 11534-164_252a4044-8b7f-4d7f-b501-3d089ca4bb5a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guiafenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sunrise Pharmaceutical Inc
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2005-07-08
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN
- Active strength
- 400 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11534-164-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1a82-f424-e053-dadaa90a57ce | Guaifenesin 400 mg Expectorant |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11534-164-01 | Guiafenesin | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUIAFENESIN TABLET [SUNRISE PHARMACEUTICAL INC] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 359601 | guaiFENesin 400 MG Oral Tablet | PSN | 5e3875ba-d34c-48b2-93ec-baa27f6a37a2 | 2 |
| 359601 | guaifenesin 400 MG Oral Tablet | SCD | 5e3875ba-d34c-48b2-93ec-baa27f6a37a2 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 11534-164-01 | 11534016401 | 100 in 1 BOTTLE | Historical |