FDA.reportPublic FDA data

Guaifenesin

Product NDC
0904-5154
11-digit product format
009045154
Labeler code
0904
Product ID
0904-5154_9a9743de-1619-4d95-868f-d125b1d409e4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-05
Substance
GUAIFENESIN
Active strength
200 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

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 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
197741Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa662428-e61f-4e22-af4d-8cf63df68c99Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5154-60Guaifenesin100 in 1 BOTTLE, PLASTICTABLET10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5154-60EA - Each0904-51540d39630a-f133-4d2c-bf29-7ec9c4ac5ca912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
POVIDONESINACTIVE INGREDIENTFZ989GH94EGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]13
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5154GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS]25Current NDC, Legacy NDC, 1 package rows20250512_aa662428-e61f-4e22-af4d-8cf63df68c99.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 100 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
application number: M012
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
application number: M012
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3fa17255-514f-db47-e063-6294a90ae4542025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197741guaiFENesin 200 MG Oral TabletPSNaa662428-e61f-4e22-af4d-8cf63df68c9926
197741guaifenesin 200 MG Oral TabletSCDaa662428-e61f-4e22-af4d-8cf63df68c9926
197741guaiFENesin 200 MG Oral TabletPSN15c87250-7c30-4565-b451-b87c6754a3712
197741guaiFENesin 200 MG Oral TabletPSN9de5e639-d676-4379-9cb5-d99014ebca6c2
197741guaifenesin 200 MG Oral TabletSCD15c87250-7c30-4565-b451-b87c6754a3712
197741guaifenesin 200 MG Oral TabletSCD9de5e639-d676-4379-9cb5-d99014ebca6c2
197741guaiFENesin 200 MG Oral TabletPSNbf32f7e3-2973-434a-a3c5-7e40bedf5f2a1
197741guaifenesin 200 MG Oral TabletSCDbf32f7e3-2973-434a-a3c5-7e40bedf5f2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5154-6000904515460100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60) 100 tablet2009-10-050000-00-00NoNoCurrent