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 105 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92025-10-02WarningsExact identifier
application number: M012
Vicks NyQuil Cough DM plus CongestionDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyc4d38921-ec90-0658-e053-2a95a90a848a2025-10-02WarningsExact identifier
application number: M012
Vicks Formula 44 VapoCool Cough and Chest CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINThe Procter & Gamble Manufacturing Companyd3bfce81-9e6d-6741-e053-2a95a90af1832025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil Kids Honey and Vicks NyQuil Kids Honey COLD and COUGH plusDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefa53214-b2e0-cfd0-e053-2a95a90abbdf2025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyc6f13d96-5136-63a0-e053-2a95a90af6dc2025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil COLD and FLUACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyefb92829-1007-1c5d-e053-2a95a90a3c9b2025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb982d4-93d0-815f-e053-2995a90a82dd2025-10-02WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsExact identifier
application number: M012
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
application number: M012
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
application number: M012
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
application number: M012
VICKS VapoRubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOLProcter & Gamble Manufactura S de RL de CV0a3086b7-a670-474e-81cf-8f989af425c22025-10-01WarningsExact identifier
application number: M012
Vicks VapoRub ADVANCED PLUSCAMPHOR, EUCALYPTUS OIL, MENTHOLProcter & Gamble Manufacturing GmbHf801128c-94bb-fa9e-e053-6294a90a08222025-10-01WarningsExact identifier
application number: M012
Vicks VapoRubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLProcter & Gamble Manufactura S de RL de CV699691ae-d2a1-a8bb-e053-2991aa0acfea2025-10-01WarningsExact identifier
application number: M012
Vicks childrens VapoRubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOLProcter & Gamble Manufactura S de RL de CV00f2fd0e-2608-6c06-e063-6294a90a066a2025-10-01WarningsExact identifier
application number: M012
Vicks VapoRubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLProcter & Gamble Manufactura S de RL de CV699879f9-4a7e-3680-e053-2a91aa0a44af2025-10-01WarningsExact 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

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