FDA.reportPublic FDA data

GUAIFENESIN

Product NDC
0121-1744
11-digit product format
001211744
Labeler code
0121
Product ID
0121-1744_25a970c7-0016-4f22-9e94-1e20e1319e3e
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-09-01
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
GUAIFENESIN
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
c2e53fb5-2798-47c8-9285-d1077d46e629Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1744-00GUAIFENESIN10 in 1 CASESOLUTION109
0121-1744-00GUAIFENESIN10 in 1 TRAYSOLUTION109
0121-1744-05GUAIFENESIN5 mL in 1 CUP, UNIT-DOSESOLUTION59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1744-00ML - Milliliter0121-1744171bdc6a-7b5f-45a7-87e1-b202b3ef5ad412018-01-12
0121-1744-05ML - Milliliter0121-174480ee20cf-4e2b-4882-bcd2-cbd2ec3f467112014-10-03
0121-1744-10ML - Milliliter0121-174429730dba-fb62-49e5-b8f8-98345a3002ea12014-10-03
0121-1744-15ML - Milliliter0121-17448868bbf3-ee16-4fa4-8362-f51827a901a012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN LIQUID [CARDINAL HEALTH]3
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN LIQUID [CARDINAL HEALTH]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GUAIFENESIN LIQUID [CARDINAL HEALTH]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGUAIFENESIN LIQUID [CARDINAL HEALTH]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SGUAIFENESIN LIQUID [CARDINAL HEALTH]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUAIFENESIN LIQUID [CARDINAL HEALTH]3
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GUAIFENESIN LIQUID [CARDINAL HEALTH]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAIFENESIN LIQUID [CARDINAL HEALTH]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGUAIFENESIN LIQUID [CARDINAL HEALTH]3
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN LIQUID [CARDINAL HEALTH]3
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1744GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 3 package rows20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.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 81 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max GelsACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dec468-fbb2-3489-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.d7711cd6-5058-548d-e053-2a95a90ac54d2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.a2f0285b-8550-fd26-e053-2995a90ab6152025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.f6c73f61-f4fc-377f-e053-6294a90a37972025-12-04WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast FizzDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBayer Healthcare LLC.a32e2a5e-9aa0-4e7c-e053-2995a90a31902025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e2877488-3539-cba2-e053-2995a90a60052025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChewsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.14951faa-9476-6f29-e063-6394a90a14c72025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid GelsALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTIONBayer HealthCare LLC.0c120569-622d-3a23-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChewsCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.149330be-24bd-b4a4-e063-6394a90a90072025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESINBayer HealthCare LLC.5278a128-41ec-4494-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.53188c41-3f13-311b-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.75894849-a0ba-57be-e053-2a91aa0a049a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.531ab703-179a-70ad-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.7588ea67-68a9-4dc0-e053-2991aa0aa4712025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid GelsACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.20ae92d9-fbc6-5b7a-e063-6294a90a15c32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51c44970-06e5-082e-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.54236151-37db-0b5a-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.52542774-fd05-640c-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 20 MG/ML Oral SolutionSCD888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 100 MG per 5 ML Oral SolutionSY888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 100 MG per 5 ML Oral SyrupSY888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 200 MG per 10 ML Oral SolutionSY888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 300 MG per 15 ML Oral SolutionSY888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaifenesin 400 MG per 20 ML Oral SolutionSY888b6a2e-6631-4585-a7fe-eb122eb51b2310
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 20 MG/ML Oral SolutionSCDc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 100 MG per 5 ML Oral SolutionSYc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 100 MG per 5 ML Oral SyrupSYc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 200 MG per 10 ML Oral SolutionSYc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 300 MG per 15 ML Oral SolutionSYc2e53fb5-2798-47c8-9285-d1077d46e6299
310604guaifenesin 400 MG per 20 ML Oral SolutionSYc2e53fb5-2798-47c8-9285-d1077d46e6299

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1744-000012117440010 TRAY in 1 CASE (0121-1744-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1744-05) 10 tray2002-09-010000-00-00NoNoCurrent
0121-1744-05001211744055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-1744-100012117441010 TRAY in 1 CASE (0121-1744-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE10 tray2002-09-010000-00-00NoNoCurrent
0121-1744-150012117441510 TRAY in 1 CASE (0121-1744-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE10 tray2002-09-010000-00-00NoNoCurrent