FDA.reportPublic FDA data

Guaifenesin STRAWBERRY-BANANA FLAVOR

Product NDC
71800-059
11-digit product format
718000059
Labeler code
71800
Product ID
71800-059_37de006a-e717-a4e5-e063-6394a90abd8b
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Innovida Pharmaeutique Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
GUAIFENESIN
Active strength
100 mg/5mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin STRAWBERRY-BANANA FLAVOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

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
1006906e-d6d7-4f49-92bf-3cb2d2cdbb16Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
71800-059-19Guaifenesin STRAWBERRY-BANANA FLAVOR119 mL in 1 TUBELIQUID1191

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-059-19ML - Milliliter71800-059d3fa3ffd-d057-44a7-b7b8-f8d657a3803c12026-04-20

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 55 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Tylenol Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.618ce449-5ad6-4e53-bbf6-152a907c493e2026-01-06WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.1560b3a0-fe81-4e33-b581-20b43511dba32026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBi-Martf27bb9d1-9880-41f6-b500-42cb5957052a2026-01-02WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 20 MG/ML Oral SolutionSCD1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 100 MG per 5 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 100 MG per 5 ML Oral SyrupSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 200 MG per 10 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 300 MG per 15 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161
310604guaifenesin 400 MG per 20 ML Oral SolutionSY1006906e-d6d7-4f49-92bf-3cb2d2cdbb161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71800-059-1971800005919119 mL in 1 TUBE (71800-059-19) 119 ml2025-06-16NoNoCurrent