Guaifenesin 200mg
- Product NDC
- 10135-789
- 11-digit product format
- 101350789
- Labeler code
- 10135
- Product ID
- 10135-789_5ec48672-dd43-5e2c-e063-6294a90aee57
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-01
- Substance
- GUAIFENESIN
- Active strength
- 200 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin 200mg
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 200 mg/1 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-789-01 | Guaifenesin 200mg | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-789-01 | EA - Each | 10135-789 | 601de2dd-3623-460f-9cb3-33bbcb48bb5e | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| UP AND UP NO DRIP NASAL | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 760d6d0f-00fc-40bc-858d-83a0827d139f | 2025-01-29 | Warnings | M012 |
| Guaifenesin and Dextromethorphan | GUAIFENESIN AND DEXTROMETHORPHAN | Major Pharmaceuticals | 51e48201-bb62-4e89-85eb-e4a416f93522 | 2025-01-29 | Warnings | M012 |
| Severe Congestion and Cough Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 8c878e47-94f4-484f-bdd8-6d87ac2440d8 | 2025-01-28 | Warnings | M012 |
| Cough and Cold Therapy | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088be461-7afc-586a-e063-6294a90a700b | 2025-01-27 | Warnings | M012 |
| Cough and Cold Therapy For Kids | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Everlaan Organics Inc | 088df369-114c-db4f-e063-6394a90acfac | 2025-01-27 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a | 2025-01-26 | Warnings | M012 |
| Walgreens Menthol Cough Drops | MENTHOL | Walgreens | 2c62f690-8dfb-d28e-e063-6394a90a45a2 | 2025-01-23 | Warnings | M012 |
| Walgreens Cherry Cough Drops | MENTHOL | Walgreens | 2c65d836-e724-50d6-e063-6394a90a0827 | 2025-01-23 | Warnings | M012 |
| Walgreens Honey Lemon Cough Drops | MENTHOL | Walgreens | 2c67424c-2fb0-cc15-e063-6394a90a02ca | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Analgesic Gel | MENTHOL | American Consumer Products Corp | 6f0725f2-833f-f3a0-e053-2a91aa0a3911 | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 | 2025-01-23 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Best Choice | 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d | 2025-01-22 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 26a02737-2cfd-769f-e063-6394a90af352 | 2025-01-22 | Warnings | M012 |
| Pharbechlor | CHLORPHENIRAMINE MALEATE 4MG | Ulai Health LLC | 6a1a5cef-e946-4ba8-9402-557c6adf45f9 | 2025-01-20 | Warnings | M012 |
| Pharbinex | GUAIFENESIN 400MG | Ulai Health LLC | 4eafa81a-aeee-4c97-85d6-594902b10919 | 2025-01-20 | M012 | |
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197741 | guaiFENesin 200 MG Oral Tablet | PSN | 13b8f480-d1ac-d70c-e063-6394a90ab4f4 | 2 |
| 197741 | guaifenesin 200 MG Oral Tablet | SCD | 13b8f480-d1ac-d70c-e063-6394a90ab4f4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10135-789-01 | 10135078901 | 100 TABLET in 1 BOTTLE (10135-789-01) | 100 tablet | 2024-03-01 | No | No | Current |