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

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
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 59 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and Flu Liquid CherryACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEGrimann, S.A. de C.V.fe2dd0d7-36ff-154e-e053-6394a90a88d42026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact identifier
application number: M012
Seacall Nasal Spray.NASAL SPRAYGuangdong Quadrant Ecological Technology Co., Ltd.1f12618b-7461-fb47-e063-6294a90af7532026-01-23WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company32f95ea0-3f39-914b-e063-6294a90a2c612026-01-23WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf7d210-102c-4053-81f6-67116de6cf7b2026-01-23WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergen44f9255b-0bf9-4573-ac9c-410acb515bc22026-01-23WarningsExact identifier
application number: M012
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
application number: M012
good neighbor pharmacy night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergene2b5c27e-ca5f-4503-a3ce-c86e1d8070a72026-01-23WarningsExact identifier
application number: M012
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL COLD and FLUACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company32819305-9bbd-8843-e063-6294a90a7f2e2026-01-22WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company32819644-9f07-9f70-e063-6294a90a72232026-01-22WarningsExact identifier
application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR GUAIFENESINStrategic Sourcing Services LLC84750bfb-9e94-40a3-b731-21799f5e4fd12026-01-20WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact 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