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 135 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf4468840-e17c-6888-e053-2995a90a04a02024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact 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