FDA.reportPublic FDA data

Adult Tussin

Product NDC
69230-332
11-digit product format
692300332
Labeler code
69230
Product ID
69230-332_62155505-522d-4269-8d03-599c6d2c902c
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Consumer Care
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-19
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Adult Tussin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

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
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
896d2540-279a-4405-b176-acbff56303e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-332-23Adult Tussin237 mL in 1 BOTTLESOLUTION2371
69230-332-23Adult Tussin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-332ADULT TUSSIN (GUAIFENESIN) SOLUTION [CAMBER CONSUMER CARE]1Current NDC, 2 package rows20250523_896d2540-279a-4405-b176-acbff56303e5.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 42 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17b8f17-95f6-37e4-e053-2995a90a411a2026-03-26WarningsExact identifier
application number: M012
Ultra concentrated Daytime/ Nighttime Severe SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGELCVS PHARMACY, INC24cedaec-06a6-8fde-e063-6394a90a3d7a2026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079537-1c06-1373-e063-6394a90a37d22026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2fa8c-071f-50ab-e063-6394a90a4a4a2026-03-26WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
application number: M012
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
application number: M012
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
application number: M012
childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inc686f43ea-4296-4eee-b762-9a9e683443402026-03-26WarningsExact identifier
application number: M012
Tussin DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59d3a486-97c2-4e60-90e2-1b5bfa7638c72026-03-26WarningsExact identifier
application number: M012
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
application number: M012
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
application number: M012
Walgreens Lavender Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a1a00-852d-2756-e063-6394a90a5e292026-03-25WarningsExact identifier
application number: M012
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company2d56ddcd-3cc8-51eb-e063-6394a90ae7452026-03-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETWIN MED LLC7b000478-649d-4511-b3e0-eea6995b97842026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f32457-23bf-d8a8-e063-6294a90a1e0d2026-03-25WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEMedical Group Care LLCf4a9ba87-c2a1-2de0-e053-2a95a90ada4c2026-03-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 20 MG/ML Oral SolutionSCD896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 100 MG per 5 ML Oral SolutionSY896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 100 MG per 5 ML Oral SyrupSY896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 200 MG per 10 ML Oral SolutionSY896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 300 MG per 15 ML Oral SolutionSY896d2540-279a-4405-b176-acbff56303e51
310604guaifenesin 400 MG per 20 ML Oral SolutionSY896d2540-279a-4405-b176-acbff56303e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69230-332-23692300332231 BOTTLE in 1 CARTON (69230-332-23) / 237 mL in 1 BOTTLE1 bottle2025-05-20NoNoCurrent