Leader Adult Tussin Mucus and Chest Congestion 541

Product NDC
70000-0696
11-digit product format
700000696
Labeler code
70000
Product ID
70000-0696_d7fae410-9c1c-4231-9fde-2c51ad3d7e95
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-20
Substance
GUAIFENESIN
Active strength
200 mg/10mL
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
Leader Adult Tussin Mucus and Chest Congestion 541
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

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
1606850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7fae410-9c1c-4231-9fde-2c51ad3d7e95Available 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
70000-0696-1Leader Adult Tussin Mucus and Chest Congestion 541118 mL in 1 BOTTLELIQUID1181
70000-0696-1Leader Adult Tussin Mucus and Chest Congestion 5411 in 1 CARTONLIQUID11
70000-0696-2Leader Adult Tussin Mucus and Chest Congestion 541237 mL in 1 BOTTLELIQUID2371
70000-0696-2Leader Adult Tussin Mucus and Chest Congestion 5411 in 1 CARTONLIQUID11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0696-1ML - Milliliter70000-069644710a7e-f55d-4b69-9471-e0b5957d721512025-10-14
70000-0696-2ML - Milliliter70000-0696d2e80e9a-1023-4243-b96f-ba44776f0aed12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0696LEADER ADULT TUSSIN MUCUS AND CHEST CONGESTION 541 (GUAIFENESIN) LIQUID [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, 4 package rows20240922_d7fae410-9c1c-4231-9fde-2c51ad3d7e95.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 56 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVEREACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreensca3c1eb4-6099-5e5f-e053-2995a90ab61b2026-01-19WarningsExact identifier
application number: M012
SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENSfe6dff90-18f1-491e-84b9-cc74bb1831ba2026-01-19WarningsExact identifier
application number: M012
Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens Companyec8c73d5-b190-432a-92c6-68ea0fc86ea62026-01-19WarningsExact identifier
application number: M012
Walgreens NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREEN COMPANY5bf72e2f-15c8-466a-9e13-50654233da912026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreens9862f84d-1c18-4ef7-86dc-98572599d4172026-01-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens37853689-c9ca-4bc7-9c5b-4a68b8d778be2026-01-19WarningsExact identifier
application number: M012
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc2f762c24-2442-506a-e063-6394a90a3b962026-01-19WarningsExact identifier
application number: M012
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsExact identifier
application number: M012
nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Incf681d986-9838-42d8-8ed9-732a39fbf8702026-01-19WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLH E B22d241c5-a3fd-4619-8147-91d7a4c8cf982026-01-19WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLBetter Living Brands, LLC9fe63ca6-3863-4175-9aec-ecd6ebbdb2492026-01-19WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen5749ce9d-e182-478f-ab88-b520a35a99a72026-01-19WarningsExact identifier
application number: M012
Foster and Thrive Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC1d9150b1-2f6c-4c33-8c93-3ed1d88585e22026-01-18WarningsExact identifier
application number: M012
HealthWise Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcarece3ceffd-3ff5-3795-e053-2995a90a827f2026-01-18WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC31210a95-f9dc-49db-aab5-25c4dca492662026-01-17WarningsExact identifier
application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf77226c0-b6d5-9fd0-e053-6294a90a4b572026-01-16WarningsExact identifier
application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf691734b-5cf4-6eb8-e053-2a95a90aee802026-01-16WarningsExact identifier
application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf771aa19-295a-9f4e-e053-6294a90a16742026-01-16WarningsExact identifier
application number: M012
CVS Cherry Cough DropsMENTHOLCVS Pharmacyde5c4b94-0420-5d43-e053-2995a90aa5a52026-01-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1606850guaiFENesin 200 MG in 10 mL Oral SuspensionPSNd7fae410-9c1c-4231-9fde-2c51ad3d7e951
1606850guaifenesin 20 MG/ML Oral SuspensionSCDd7fae410-9c1c-4231-9fde-2c51ad3d7e951
1606850guaifenesin 200 MG per 10 ML Oral SuspensionSYd7fae410-9c1c-4231-9fde-2c51ad3d7e951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0696-1700000696011 BOTTLE in 1 CARTON (70000-0696-1) / 118 mL in 1 BOTTLE1 bottle2024-09-20NoNoCurrent
70000-0696-2700000696021 BOTTLE in 1 CARTON (70000-0696-2) / 237 mL in 1 BOTTLE1 bottle2024-09-20NoNoCurrent