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 |
|---|---|---|---|---|---|---|
| Dizziness HP | CALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM, | Energique, Inc. | 0bf53ecc-c2ad-40b5-b921-7c10a1b00626 | 2025-11-19 | Warnings | ETJ7Z6XBU4 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | 495W7451VQ |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | 495W7451VQ |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | 495W7451VQ |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | c5ea5a7a-c806-e5e0-e053-2995a90a15e9 | 2025-11-17 | Warnings | 495W7451VQ |
| Formica Stibium comp. | FORMICA STIBIUM COMP. | Uriel Pharmacy Inc. | 439073f2-1dee-4b4e-a65e-74aee1c73c2b | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Lavender Quartz Ear Oil | LAVENDER QUARTZ EAR OIL | Uriel Pharmacy Inc. | b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Polygonatum Cepa | POLYGONATUM CEPA | Uriel Pharmacy Inc. | 6ba0ac36-16cc-49bd-b37f-90cf18acbd5a | 2025-11-17 | Warnings | ETJ7Z6XBU4 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | f701a6ae-200d-48dc-94e4-6bd3228f50d4 | 2025-11-15 | Warnings | 495W7451VQ |
| MULTI-SYMPTOM COLD | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b1fae7cc-4033-44bc-aa7c-ca3ceea51c7d | 2025-11-15 | Warnings | 495W7451VQ |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 2025-11-15 | Warnings | 495W7451VQ |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | AmeriSource Bergen | 4a8df3c9-bed3-4371-a1c1-59afe12203e2 | 2025-11-14 | Warnings | 6V9V2RYJ8N |
| Bambusa Viscum Stannum | BAMBUSA VISCUM STANNUM | Uriel Pharmacy Inc. | 7b2a95d0-6f51-4a6b-b05f-fe7d13d83b89 | 2025-11-14 | Warnings | ETJ7Z6XBU4 |
| PECGEN DMX | DEXTROMETHORPHAN HBR, GUAIFENESIN | KRAMER NOVIS | a627824c-5e3d-4672-a047-6c801b50b432 | 2025-11-14 | Warnings | 495W7451VQ |
| Supress DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | KRAMER NOVIS | 7da0611e-729c-4cf8-88f3-f8877b9f5cfa | 2025-11-14 | Warnings | 495W7451VQ |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 85b98fa3-376c-41a3-b3c1-0c739d903a22 | 2025-11-14 | Warnings, Adverse reactions | 6V9V2RYJ8N |
| G-ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc | 2025-11-14 | Warnings | 495W7451VQ |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Ohm Laboratories Inc. | 87ab4578-84de-475d-a4b0-eec969f17253 | 2025-11-13 | Warnings | 6V9V2RYJ8N |
| Guaifenesin 400mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13f4db4e-687e-9d7b-e063-6294a90ab088 | 2025-11-13 | Warnings | 495W7451VQ |
| Guaifenesin 200mg | GUAIFENESIN | Marlex Pharmaceuticals Inc | 13b8f480-d1ac-d70c-e063-6394a90ab4f4 | 2025-11-13 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.