NDC 70677-1011-01 - Guaifenesin and Pseudoephedrine HCl
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 70677-1011
- Requested NDC
- 70677-1011-01
- Package NDCs from labels
- 70677-1011-1, 70677-1011-01
- Manufacturer
- Strategic Sourcing Services, LLC | Dr. Reddys Laboratories Limited (SEZ UNIT)
- Effective date
- 2025-12-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Drug Facts | Strategic Sourcing Services, LLC | Dr. Reddys Laboratories Limited (SEZ UNIT) | 2025-12-10 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-1011-1 | Guaifenesin and Pseudoephedrine HCl | 18 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 18 | 2 | |
| 70677-1011-1 | Guaifenesin and Pseudoephedrine HCl | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-1011 | GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC] | 1 | Current NDC, 2 package rows | 20230422_51ec068b-e219-381a-384b-a208a306d5ba.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-1011-1 | EA - Each | 70677-1011 | bd89b2fc-309f-405e-a0cd-fa8f42249b24 | 1 | 2023-09-05 |
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 |
|---|---|---|---|---|---|---|
| Topcare Health Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Topco Associates LLC | 9c614c0e-5862-682f-e053-2a95a90abc09 | 2023-12-20 | Warnings | FZ989GH94E |
| HEB Dry Eye Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | HEB | f80023cf-8e42-780a-e053-6294a90a66cd | 2023-12-20 | Warnings | 3NXW29V3WO |
| TopCare Health Advanced Moisturizing Plus Redness Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Topco Associates LLC | 9c6193a6-d822-1b27-e053-2995a90ab3cf | 2023-12-20 | Warnings | FZ989GH94E |
| HEB Advanced Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | HEB Grocery Company, LP | f76281d6-3aea-349b-e053-6394a90afca2 | 2023-12-20 | Warnings | FZ989GH94E |
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED | Lil' Drug Store Products, Inc. | e79d92d2-d73c-d44f-e053-2995a90a03d9 | 2023-12-15 | Warnings | 495W7451VQ |
| GenTeal Tears (Moderate) | DEXTRAN 70, GLYCERIN, HYPROMELLOSE | Alcon Laboratories, Inc. | a2992597-3490-6a5c-be45-2b6fa15e1547 | 2023-12-15 | Warnings | 3NXW29V3WO |
| Non-Drowsy Sinus Severe, Circle K | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store products, Inc. | e78c456f-f62e-596d-e053-2995a90a2397 | 2023-12-14 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | BluePoint Laboratories | ee8a2a97-16aa-0f3e-e053-2a95a90a523b | 2023-12-12 | Warnings | 495W7451VQ |
| Mucinex | GUAIFENESIN | A-S Medication Solutions | 92a70574-c373-4261-b20d-8ea8ef677bcf | 2023-12-09 | Warnings | 495W7451VQ |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | afc95c82-18da-487b-b4bb-51e0be0378da | 2023-12-04 | Warnings | 495W7451VQ |
| TopCare Day Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 14d53907-a4a2-4a0f-b2d6-33474945f9e1 | 2023-12-04 | Warnings | 495W7451VQ |
| Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Proficient Rx LP | 73e12596-6dd5-4cd2-83ed-992e1211b4b8 | 2023-12-01 | Warnings | FZ989GH94E |
| Guaifenesin | GUAIFENESIN | Better Living Brands LLC | ba6ccfc6-d2f8-56d0-e053-2a95a90af6a8 | 2023-12-01 | Warnings | 495W7451VQ |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Meijer | c051be4b-88c9-e56f-e053-2995a90a3aa8 | 2023-12-01 | Warnings | 1305603 6V9V2RYJ8N 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Ahold U.S.A., Inc, | 738bbea4-4243-4cbd-980e-a22451b85c4c | 2023-12-01 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | Aurohealth LLC | 84117b6e-4eeb-42b0-90b1-331f70d5a175 | 2023-12-01 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | RITE AID CORPORATION | de16ec42-4a31-4b18-e053-2995a90a78a4 | 2023-12-01 | Warnings | 495W7451VQ |
| Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Winco Foods, LLC. | ac1c8633-4064-4e2f-9b43-4ae9bdd1a427 | 2023-12-01 | Warnings | 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Ahold U.S.A., Inc, | e9add770-58e0-4cf3-bbc2-d293ca870b03 | 2023-12-01 | Warnings | 495W7451VQ |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | KROGER COMPANY | b97aeb2c-07ac-d00e-e053-2a95a90abf40 | 2023-12-01 | Warnings | 1305603 6V9V2RYJ8N 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.