FDA.reportPublic FDA data

NDC 79481-1002-01 - Guaifenesin and Pseudoephedrine HCl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
79481-1002
Requested NDC
79481-1002-01
Package NDCs from labels
79481-1002-1, 79481-1002-01
Manufacturer
Meijer | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GUAIFENESIN - Meijer | Aurohealth LLC | APL HEALTHCARE LIMITEDMeijer | Aurohealth LLC | APL HEALTHCARE LIMITED2023-12-01Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-1002-1Guaifenesin and Pseudoephedrine HCl18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE183
79481-1002-1Guaifenesin and Pseudoephedrine HCl1 in 1 CARTONTABLET, EXTENDED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-1002GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [MEIJER]3Current NDC, Legacy NDC, 2 package rows20231202_c051be4b-88c9-e56f-e053-2995a90a3aa8.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 32 of 106 · 2,106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
unii: 495W7451VQ
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
tussin cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation13618054-d0c5-4190-b626-e7e91b8557382026-01-06WarningsExact identifier
unii: 495W7451VQ
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
unii: 495W7451VQ
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC77e4132e-470e-4fb4-bc2f-df2e59061ba92026-01-06WarningsExact identifier
unii: 6V9V2RYJ8N
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
unii: 495W7451VQ
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
unii: 6V9V2RYJ8N
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
unii: 495W7451VQ
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
unii: 495W7451VQ
ParathyroparSYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, PARATHYROID GLAND (BOVINE), RHUS TOX, SILICEAEnergique, Inc.6b098910-2f36-4757-a463-e01105340c432026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Brompheniramine, Pseudoephedrine, DextromethorphanBROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHANAscend Laboratories, LLC036b587a-7bfe-4149-bd05-34a37e3e84b62026-01-02Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
unii: 495W7451VQ
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
unii: 495W7451VQ
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
unii: 495W7451VQ
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact identifier
unii: 495W7451VQ
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
unii: 495W7451VQ
Ninjacof-DCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDECenturion Labs, LLC5188aa20-41f1-4998-81e1-f4de055874bc2025-12-31WarningsExact identifier
unii: 6V9V2RYJ8N
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
unii: 495W7451VQ
Llorens Care TussinGUAIFENESINLlorens Pharmaceutical International Division, Inc.474459c1-bfd7-dec7-e063-6394a90ac18d2025-12-31WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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