FDA.reportPublic FDA data

Guaiasorb

Product NDC
57896-736
11-digit product format
578960736
Labeler code
57896
Product ID
57896-736_29f8c7e3-c785-5fd8-e063-6394a90af0ca
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Guaiasorb
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6299e352-116e-43f2-b40f-c704a7bd5d61Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-736-042021-03-15C16284748780-1ba0f9c33-29ef-a910-e053-dadaa90a0b85GeriCare-GuaiasorbDM 736
57896-736-042021-01-29C16284748780-1ba0f9c33-29ef-a910-e053-dadaa90a0b85GeriCare-GuaiasorbDM 736

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-736-04GuaiasorbDM118 mL in 1 BOTTLELIQUID1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-736-04ML - Milliliter57896-7367d8181b3-41c7-467a-8bea-5442965bf74b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-736GUAIASORB DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GERI-CARE PHARMACEUTICALS, CORP]5Current NDC, Legacy NDC, 1 package rows20241225_6299e352-116e-43f2-b40f-c704a7bd5d61.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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar GeneralNASAL PHENYLEPHRINE HYDROCHLORIDEDOLGENCORP, INC. (DOLLAR GENERAL & REXALL)e8fd3f0e-a023-4423-8906-17ae02bc083b2026-09-03WarningsExact identifier
application number: M012
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
application number: M012
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
application number: M012
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
application number: M012
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
application number: M012
Kroger No DripALLERGY SINUSKROGER COMPANY4788bafb-8866-4a0a-b217-226513799c242026-09-02WarningsExact identifier
application number: M012
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
application number: M012
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
application number: M012
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
application number: M012
KROGER No Drip Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDEKROGER COMPANY7256e048-ad69-4322-844d-872f05e6fc8a2026-09-02WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
application number: M012
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEWALMART INC.5e6623c3-6210-4c50-94d6-5554f36876d12026-08-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN6299e352-116e-43f2-b40f-c704a7bd5d615
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6299e352-116e-43f2-b40f-c704a7bd5d615
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6299e352-116e-43f2-b40f-c704a7bd5d615
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY6299e352-116e-43f2-b40f-c704a7bd5d615
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY6299e352-116e-43f2-b40f-c704a7bd5d615
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN46a480c7-7092-b809-e063-6294a90a60cd1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD46a480c7-7092-b809-e063-6294a90a60cd1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY46a480c7-7092-b809-e063-6294a90a60cd1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY46a480c7-7092-b809-e063-6294a90a60cd1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY46a480c7-7092-b809-e063-6294a90a60cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-736-0457896073604118 mL in 1 BOTTLE (57896-736-04) 118 ml2019-10-010000-00-00NoNoCurrent