FDA.reportPublic FDA data

Guaifenesin

Manufacturer
Granules India Limited
Effective date
2025-10-24
Label type
BULK INGREDIENT
Version
16
Source
full-release
Hydrated at
2026-06-01 02:52:31

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62207-950-0262207-950-02

62207-950-0462207-950-04

62207-950-1162207-950-11

62207-950-1362207-950-13

62207-932-0262207-932-02

62207-932-0462207-932-04

62207-932-1162207-932-11

62207-932-1362207-932-13

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeQR CodeProduct Identification Code-00000000000000 Name Of API-Granules India Limited Brand Name-Granules India Limited Address-H. No. 6-5 & 6-11, Temple Rd. Address 2. Bonthapally Village. City. Gummadidala Mandal, Sangareddy District-502313.Telangana State-India. B.No.-XXXXXXXX Batch Size-000 kg Date of Manufacturing-XXX 20XX Date of Expiry-XXX 20XX SSCC-(00) 000000000000000000 Mfg.Licence No-214/MD/AP/96/B/R Storage Condition-PRESERVE IN TIGHT CONTAINERS,STORE BELOW 30°C62207-932-13.jpg, 62207-932-02.jpg, 62207-932-11.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-932-02Guaifenesin25 kg in 1 DRUMPOWDER2516
62207-932-04Guaifenesin50 kg in 1 DRUMPOWDER5016
62207-932-11Guaifenesin25 kg in 1 DRUMPOWDER2516
62207-932-13Guaifenesin50 kg in 1 DRUMPOWDER5016
62207-950-02Guaifenesin25 kg in 1 DRUMPOWDER2516
62207-950-04Guaifenesin50 kg in 1 DRUMPOWDER5016
62207-950-11Guaifenesin25 kg in 1 DRUMPOWDER2516
62207-950-13Guaifenesin50 kg in 1 DRUMPOWDER5016

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-95062207-950-11, 62207-950-02, 62207-950-04, 62207-950-13
62207-93262207-932-02, 62207-932-04, 62207-932-11, 62207-932-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152024-03-08full-release2026-06-01 02:51:02

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 1 of 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsName fallback
generic name: GUAIFENESIN
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsName fallback
generic name: GUAIFENESIN
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsName fallback
generic name: GUAIFENESIN
good sense mucus erGUAIFENESINL. Perrigo Companydef40c3f-29de-4efc-b1d3-4cb89183aaec2026-09-03WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsName fallback
generic name: GUAIFENESIN
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2026-08-10WarningsName fallback
generic name: GUAIFENESIN
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsName fallback
generic name: GUAIFENESIN
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsName fallback
generic name: GUAIFENESIN
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsName fallback
generic name: GUAIFENESIN
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsName fallback
generic name: GUAIFENESIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.