FDA.reportPublic FDA data

DG Health Immediate Release Mucus Relief

Product NDC
10956-059
11-digit product format
109560059
Labeler code
10956
Product ID
10956-059_1938e502-ee72-400d-933c-271efa88dc69
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reese Pharmaceutical Co
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DG Health Immediate Release Mucus Relief
Listing expiration
2026-12-31

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
f60a9d1b-7a63-43d3-b843-e1f31cf78873Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-059-30DG Health Immediate Release Mucus Relief1 in 1 CARTONTABLET13
10956-059-30DG Health Immediate Release Mucus Relief30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-059DG HEALTH IMMEDIATE RELEASE MUCUS RELIEF (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]3Current NDC, Legacy NDC, 2 package rows20241220_f60a9d1b-7a63-43d3-b843-e1f31cf78873.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 106 of 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SalineNASALHEB520e20a3-1e16-4cbd-9da3-948747f4f51d2025-10-03WarningsExact identifier
application number: M012
heb nasalPHENYLEPHRINE HYDROCHLORIDEH E B2cf319cc-bb49-4b7d-bb08-e3346b4a78d42025-10-03WarningsExact identifier
application number: M012
VICKS DayQuil SEVERE NyQuil SEVERE HONEY FLAVOR COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyfd03769c-2fd6-1c22-e053-6394a90a12f62025-10-03WarningsExact identifier
application number: M012
VICKS FORMULA 44DM NIGHTTIME COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATEProcter & Gamble Manufacturing Company05414779-f61d-8fa7-e063-6394a90aa0342025-10-03WarningsExact identifier
application number: M012
VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLUACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLProcter & Gamble Manufacturing Company04ca1e9c-f297-cbd6-e063-6294a90a37392025-10-03WarningsExact identifier
application number: M012
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil ELDERBERRY COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company1b569c65-437c-1dbc-e063-6394a90a04aa2025-10-03WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
application number: M012
Guaifenesin 400GUAIFENESIN TABLETS 400InvaTech Pharma Solutions LLC40291505-55ca-0759-e063-6394a90acee12025-10-02Exact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402025-10-02WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282025-10-02WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNf60a9d1b-7a63-43d3-b843-e1f31cf788733
359601guaifenesin 400 MG Oral TabletSCDf60a9d1b-7a63-43d3-b843-e1f31cf788733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10956-059-30109560059301 BOTTLE, PLASTIC in 1 CARTON (10956-059-30) / 30 TABLET in 1 BOTTLE, PLASTIC2013-12-010000-00-00NoNoCurrent