GUAIFENESIN 400MG CAPLETS
- Product NDC
- 77333-360
- 11-digit product format
- 773330360
- Labeler code
- 77333
- Product ID
- 77333-360_48032e44-d1b5-ea4d-e063-6394a90aba26
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Gendose Pharmaceuticals, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-02
- Substance
- GUAIFENESIN
- Active strength
- 400 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 77333-360 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 77333-360 | 77333-360-10 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
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 400MG CAPLETS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 400 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 359601 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e7b82ec7-ef23-50c1-e053-2a95a90a662f | Available on FDA.report |
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 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 |
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 |
|---|---|---|---|---|---|---|
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb | 2026-04-09 | Warnings | M012 |
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | e20b1093-d77f-4c39-b105-adaa1b82ea76 | 2026-04-09 | Warnings | M012 |
| Alka Seltzer Cold Cold and Congestion Severe Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 4f0c1b8e-3fb1-ccf2-e063-6394a90acd15 | 2026-04-09 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Lidl US LLC | b26ac105-f8e4-4ad0-8a26-9fdf30c01700 | 2026-04-09 | Warnings | M012 |
| Wal Dryl Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 09de28cd-fa60-4af7-b7cc-cf74c00a3531 | 2026-04-09 | Warnings | M012 |
| Tussin DM Max NIGHTTIME | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | d10a413e-22a6-4799-8367-5777831756a9 | 2026-04-09 | Warnings | M012 |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 80d25e23-b108-4eb1-88c7-73fe9da8f942 | 2026-04-09 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR AND GUAIFENESIN | L.N.K. International, Inc. | 2fea3533-8218-4875-affe-5b33a22c553a | 2026-04-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Plus Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Kenvue Brands LLC | 4e60e1ad-4ad4-c329-e063-6294a90ab318 | 2026-04-08 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 2026-04-08 | Warnings | M012 |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | e24121d2-c9d2-4bbd-869e-eeed7e2bb881 | 2026-04-08 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 8460d4f9-8d7b-4ae4-8047-c2010d9c8013 | 2026-04-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | d2dab450-cf82-4be2-a4e2-630295fb59ab | 2026-04-08 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 4657c02b-887b-4746-8a78-83a72465e07b | 2026-04-08 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 33646fab-79a5-4f10-8ac0-48423eac9b56 | 2026-04-07 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 76e19b9a-3bdb-479a-9503-9e8250109c84 | 2026-04-07 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 7959ea00-2a41-4c3c-8c58-85795ebd2afc | 2026-04-06 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Preferred Pharmaceuticals Inc. | da148c1d-e394-4367-83e0-533469501b30 | 2026-04-06 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | TOP CARE (Topco Associates LLC) | b2ebfeb3-e248-40bf-81d3-81c5fb532dbe | 2026-04-06 | Warnings | M012 |
| Allergy Plus Sinus Relief | DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | Rite Aid Corporation | 54623e2e-5f9a-426e-8f7e-ea755ff8b3f8 | 2026-04-06 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 359601 | guaiFENesin 400 MG Oral Tablet | PSN | e7b82ec7-ef23-50c1-e053-2a95a90a662f | 7 |
| 359601 | guaifenesin 400 MG Oral Tablet | SCD | e7b82ec7-ef23-50c1-e053-2a95a90a662f | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 77333-360-10 | 77333036010 | 100 BLISTER PACK in 1 BOX (77333-360-10) / 1 TABLET in 1 BLISTER PACK (77333-360-25) | 100 blister pack | 2022-09-02 | 0000-00-00 | No | No | Current |
| 77333-360-25 | 77333036025 | 1 in 1 BLISTER PACK | Historical |