FDA.reportPublic FDA data

Geri-Tussin

Product NDC
57896-693
11-digit product format
578960693
Labeler code
57896
Product ID
57896-693_4744e526-723f-2ff0-e063-6294a90adc2b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-01
Substance
GUAIFENESIN
Active strength
100 mg/5mL
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
Geri-Tussin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

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
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65545ca3-4e93-4b59-9e17-4742e086e8e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57896-693-162021-03-15C16284748780-1ba0f9c33-3e85-a910-e053-dadaa90a0b85GeriCare- Tussin 693
57896-693-162021-01-29C16284748780-1ba0f9c33-3e85-a910-e053-dadaa90a0b85GeriCare- Tussin 693

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-693-04Geri-Tussin118 mL in 1 BOTTLELIQUID1188
57896-693-08Geri-Tussin237 mL in 1 BOTTLELIQUID2378
57896-693-16Geri-Tussin473 mL in 1 BOTTLELIQUID4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-693-04ML - Milliliter57896-6937f25273f-d1fc-439d-af72-925bd830bb4a12024-07-12
57896-693-08ML - Milliliter57896-693b5c35bb9-0318-4e23-b8fd-dff274ac9d7012026-01-08
57896-693-16ML - Milliliter57896-6936f03e183-fd4e-458d-b2ab-ebe17daac28b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-693GERI-TUSSIN (GUAIFENESIN) LIQUID [GERI-CARE PHARMACEUTICALS, CORP]6Current NDC, Legacy NDC, 3 package rows20241222_65545ca3-4e93-4b59-9e17-4742e086e8e7.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 147 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sinus pressure and pain peACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa7931e4c-8a5e-66e2-e053-2995a90af2a42024-10-18WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense570ea130-6a99-446e-9f97-14fc958090062024-10-18WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa14999e3-a9d9-0a1f-e053-2995a90af7b32024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa793000b-3ef9-5662-e053-2a95a90ad0da2024-10-18WarningsExact identifier
application number: M012
Cold Multi-Symptom Daytime and NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense37455f86-ab21-472b-9e80-40324699f3ca2024-10-18WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3396a27-8643-71fa-e053-2a95a90a713d2024-10-18WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3397f69-3267-ca0b-e053-2995a90a7db52024-10-18WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense747512a2-3b6d-496b-ab80-8190603141632024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN9daf7f40-d9c5-4367-be41-894208358fc12024-10-18WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen608e6808-29e4-40bc-8496-24c092681a1b2024-10-18WarningsExact identifier
application number: M012
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen665db127-ee04-46c4-bff0-e0fe9950c3e22024-10-18WarningsExact identifier
application number: M012
Cold Max Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen87a1cc06-9994-4fa9-8c64-e2ffdd33a2f82024-10-18WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen604d7e53-4bfd-4cdd-aed2-b304ae82ce442024-10-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MART4d93a703-c905-4fb3-b772-11c207065d4d2024-10-17WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART62c35320-87b5-46e2-9f6f-cb0882bdb52e2024-10-17WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dcf6cf-373c-ea83-e053-2a95a90ae57a2024-10-17WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5918-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e99dad-5916-6a90-e053-2a95a90a88032024-10-17WarningsExact identifier
application number: M012
ALLERGY MULTISYMPTOMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa7e9ab8e-2252-180d-e053-2a95a90a788f2024-10-17WarningsExact identifier
application number: M012
COLD PLUS HEAD CONGESTION SEVEREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART3430c7e4-e142-407e-bed5-358dd6bd10f72024-10-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 20 MG/ML Oral SolutionSCD65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 100 MG per 5 ML Oral SolutionSY65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 100 MG per 5 ML Oral SyrupSY65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 200 MG per 10 ML Oral SolutionSY65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 300 MG per 15 ML Oral SolutionSY65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaifenesin 400 MG per 20 ML Oral SolutionSY65545ca3-4e93-4b59-9e17-4742e086e8e78
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 20 MG/ML Oral SolutionSCDa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 100 MG per 5 ML Oral SolutionSYa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 100 MG per 5 ML Oral SyrupSYa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 200 MG per 10 ML Oral SolutionSYa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 300 MG per 15 ML Oral SolutionSYa307a54c-2861-4027-bec4-da8a984d211e2
310604guaifenesin 400 MG per 20 ML Oral SolutionSYa307a54c-2861-4027-bec4-da8a984d211e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-693-0457896069304118 mL in 1 BOTTLE (57896-693-04) 118 ml2025-06-05NoNoCurrent
57896-693-0857896069308237 mL in 1 BOTTLE (57896-693-08) 237 ml2025-12-01NoNoCurrent
57896-693-1657896069316473 mL in 1 BOTTLE (57896-693-16) 473 ml2019-05-010000-00-00NoNoCurrent