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 |
|---|---|---|---|---|---|---|
| Allergy relief-D | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Ohm Laboratories Inc. | c24f3760-70e0-410f-bf80-6d0cadcd61b9 | 2024-12-16 | Warnings | 6V9V2RYJ8N |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | 495W7451VQ |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | 495W7451VQ |
| Topcare mucus er | GUAIFENESIN | Topco Associates LLC | e3c900ad-21b1-4cd0-8c48-f54f115df403 | 2024-12-12 | Warnings | 495W7451VQ |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE | Best Choice (Valu Merchandisers Company) | 539b8972-2a46-468e-ad27-6672d746feb7 | 2024-12-10 | Warnings | 495W7451VQ |
| Head Congestion Plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 09531edc-8dbd-451f-ae02-f922e9e8c248 | 2024-12-05 | Warnings | 495W7451VQ |
| COLD AND FLU DAYTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9de99931-31ef-79e2-e053-2a95a90a98ad | 2024-12-04 | Warnings | 495W7451VQ |
| Sinus Congestion and Pain Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCare | fa9b2748-0474-4a39-a2b8-bb6f0678c1d1 | 2024-12-03 | Warnings | 495W7451VQ |
| COLD AND FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | cbb179c8-31fb-4a3a-9f23-4024350f8b7f | 2024-12-03 | Warnings | 495W7451VQ |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | e07d880b-a12a-4e5e-94c0-bd36bcfe738c | 2024-12-03 | Warnings | 495W7451VQ |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | bd0a3679-1f7c-4c41-e053-2995a90a8fcb | 2024-12-03 | Warnings | 495W7451VQ |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | bd09e4f3-3211-8c08-e053-2a95a90a73f9 | 2024-12-03 | Warnings | 495W7451VQ |
| Mucus Relief Cold and Flu All In One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | a1b281ec-fd42-963c-e053-2a95a90a4b71 | 2024-12-03 | Warnings | 495W7451VQ |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | b3366ad4-5ef4-eb70-e053-2995a90acf33 | 2024-12-03 | Warnings | 495W7451VQ |
| Tenalif Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd9513-1a42-e990-e063-6294a90a57df | 2024-12-03 | Warnings | 495W7451VQ |
| Tenalif Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd94e7-1808-3bb3-e063-6294a90a4140 | 2024-12-03 | Warnings | 495W7451VQ |
| Nasal Decongestant PE and Pain Relief Plus Mucus Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 31531f90-8933-46ab-b722-cb63e7738639 | 2024-12-03 | Warnings | 495W7451VQ |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | f45f3ab4-5e10-3004-e053-2a95a90a0cb4 | 2024-12-03 | Warnings | 495W7451VQ |
| Guaifenesin and Pseudoephedrine HCl | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Amerisource Bergen | 775000bc-56de-4c72-87da-65bb33f063b3 | 2024-12-03 | Warnings | 1305603 6V9V2RYJ8N 495W7451VQ |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 0ea270b7-9c28-49fb-9615-c4afdbdbc8f1 | 2024-12-02 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.