NDC 77333-360-25 - GUAIFENESIN 400MG CAPLETS
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
- 77333-360
- Requested NDC
- 77333-360-25
- Package NDCs from labels
- 77333-360-25, 77333-360-10
- Manufacturer
- Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED
- Effective date
- 2026-01-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| GUAIFENESIN - Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED | Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED | 2026-01-10 | HUMAN OTC DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-05-02 | GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360) |
| 2024-05-02 | GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360) |
| 2024-01-30 | GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360) |
| 2024-01-30 | GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77333-360-10 | GUAIFENESIN 400MG CAPLETS | 100 in 1 BOX | TABLET | 100 | 7 | |
| 77333-360-25 | GUAIFENESIN 400MG CAPLETS | 1 in 1 BLISTER PACK | TABLET | 1 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 77333-360-10 | EA - Each | 77333-360 | 59e4bbd3-6be1-4beb-b0d0-7887c8855797 | 1 | 2022-10-06 |
| 77333-360-25 | EA - Each | 77333-360 | 3f337a09-e952-4310-a7aa-c0fc1effdaf0 | 1 | 2022-10-06 |
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 |
|---|---|---|---|---|---|---|
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | TOPCO ASSOCIATES LLC | 3a6e96d3-ac86-f388-e063-6394a90ade2d | 2026-04-23 | Warnings | 495W7451VQ |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| GUAIFENESIN AND DEXTROMETHORPHAN HBR | GUAIFENESIN AND DEXTROMETHORPHAN HBR | TOPCO ASSOCIATES LLC | 3a9737c0-e413-dfd1-e063-6294a90aaebd | 2026-04-23 | Warnings | 495W7451VQ |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | OHM LABORATORIES INC | f2eb5494-2672-444f-afa3-d1ef8ed1eaa1 | 2026-04-22 | Warnings | 495W7451VQ |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH, | cfd43b8f-8064-6b88-e053-2a95a90a329e | 2026-04-22 | Warnings | M012 |
| Vicks Sinex Severe Original | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | cfd048c9-2f33-101d-e053-2995a90ad854 | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | d0768332-7c24-7c30-e053-2a95a90a26d4 | 2026-04-22 | Warnings | M012 |
| Histanaz | PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3e87d0f3-f16c-5972-e063-6294a90acc8a | 2026-04-22 | Warnings | M012 |
| Good Sense Severe Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | d5faf89f-3641-4be1-8d43-35504f12fe8d | 2026-04-22 | Warnings | M012 495W7451VQ |
| Multi-Symptom Cold childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd4 | 2026-04-22 | Warnings | M012 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.