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 |
|---|---|---|---|---|---|---|
| Viro-Flu AM | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC | 551c957a-2e44-2b17-e063-6394a90a5295 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93fe6d-ee21-e323-e063-6394a90a61bf | 2026-07-15 | Warnings | M012 |
| Pentrexcilina Daytime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b7b3c15a-bb28-5c25-e053-2a95a90ad3b1 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93c815-63c7-bfe0-e063-6394a90ab4a5 | 2026-07-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALMART INC. (see also Equate) | 28251229-ad84-4573-aff0-fb0bed6cdfa1 | 2026-07-15 | Warnings | M012 |
| Viro Flu PM Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | 5693f346-8214-0112-e063-6394a90aabfb | 2026-07-14 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 5fa848ef-35ee-4e05-8ff2-781d034cf6ac | 2026-07-14 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | 0fad61d8-4393-47ec-9ff6-7df5be761f5b | 2026-07-14 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Rite Aid Corporation | 211c4273-3b2c-4169-b9c6-7a87903e77cd | 2026-07-13 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | f1a4ee57-33a3-4791-a769-b208b38acb72 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY Childrens Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | c499574c-f32b-4608-bf8b-51ad44e35725 | 2026-07-13 | Warnings | M012 |
| Good NeighborChildrens Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | f442c61b-7d2c-401c-b862-acbe2282927b | 2026-07-13 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 5683b099-f029-2d08-e063-6394a90ad482 | 2026-07-13 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f673cdeb-4f8b-46b4-be92-c725d74abc55 | 2026-07-13 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | e4fca5ba-2d45-4c38-b0fd-297159d1705a | 2026-07-13 | Warnings | M012 |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | AMERISOURCE BERGEN | 0269c0fd-0d8f-4264-9025-d4dcb3c45c60 | 2026-07-13 | Warnings | M012 |
| Propolis Cooling Relief Cherry Cough Drops | MENTHOL, UNSPECIFIED FORM | Beekeeper's Naturals USA Inc | 7087566d-f24a-4508-aa25-7f42d055c43e | 2026-07-13 | Warnings | M012 |
| Sinus Pressure and Congestion Relief | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Rite Aid Corporation | 35bcf263-3296-4d9c-84c0-146a173d6e87 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Childrens Cough Relief Cherry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | a8e2fd43-b801-41ae-8d79-8ecf4a771543 | 2026-07-13 | Warnings | M012 |
| Good Neighbor No Drip Nasal Mist Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | 7872aadd-b23c-431f-8048-24eece25ca2d | 2026-07-13 | 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 |