FDA.reportPublic FDA data

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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct77333-360IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77333-36077333-360-10IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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 table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359601Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7b82ec7-ef23-50c1-e053-2a95a90a662fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-02GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-05-02GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-360-10GUAIFENESIN 400MG CAPLETS100 in 1 BOXTABLET1007
77333-360-25GUAIFENESIN 400MG CAPLETS1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-360-10EA - Each77333-36059e4bbd3-6be1-4beb-b0d0-7887c885579712022-10-06
77333-360-25EA - Each77333-3603f337a09-e952-4310-a7aa-c0fc1effdaf012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-360GUAIFENESIN 400MG CAPLETS (GUAIFENESIN) TABLET [GENDOSE PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20240504_e7b82ec7-ef23-50c1-e053-2a95a90a662f.zip

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.

Matched openFDA labels page 9 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEVERE COLD PLUS FLU DAYTIME NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS Pharmacy,Inc.6cb1d08b-e544-4084-b9ed-1e0d99a709c82026-08-14Warnings, Adverse reactionsExact identifier
application number: M012
Theraflu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY932a3d40-9b52-4e91-bc61-6fd506f2d9e62026-08-14WarningsExact identifier
application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy,Inc.91063edd-1e7e-41e9-8412-b14ef37490182026-08-14WarningsExact identifier
application number: M012
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
Best Health Caramel Apple Cough DropsMENTHOLBestco58eee9b4-d696-995f-e063-6294a90a5db02026-08-13WarningsExact identifier
application number: M012
Best Health Pumpkin Spice Cough DropsMENTHOLBestco58ef6619-9087-5f41-e063-6294a90a7da62026-08-13WarningsExact identifier
application number: M012
Best Health Bourbon Honey Cough DropsMENTHOLBestco58efdf29-83ea-03b9-e063-6294a90ad3062026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)af35c833-316a-4d21-bd3a-9b71558cadbf2026-08-12WarningsExact identifier
application number: M012
Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inccc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c2026-08-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNe7b82ec7-ef23-50c1-e053-2a95a90a662f7
359601guaifenesin 400 MG Oral TabletSCDe7b82ec7-ef23-50c1-e053-2a95a90a662f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77333-360-1077333036010100 BLISTER PACK in 1 BOX (77333-360-10) / 1 TABLET in 1 BLISTER PACK (77333-360-25) 100 blister pack2022-09-020000-00-00NoNoCurrent
77333-360-25773330360251 in 1 BLISTER PACKHistorical