FDA.reportPublic FDA data

GUAIFENESIN DM

Product NDC
0121-1276
11-digit product format
001211276
Labeler code
0121
Product ID
0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and DEXTROMETHORPHAN
Dosage form
SYRUP
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-07-01
Substance
GUAIFENESIN; DEXTROMETHORPHAN
Active strength
200; 20 mg/10mL; mg/10mL
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
GUAIFENESIN DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL
DEXTROMETHORPHAN20 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7355X3ROTSInternal 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
ff970fff-d1a3-4322-83b4-34e361431a1cAvailable 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
0121-1276-00GUAIFENESIN DM10 in 1 TRAYSYRUP108
0121-1276-00GUAIFENESIN DM10 in 1 CASESYRUP108
0121-1276-10GUAIFENESIN DM10 mL in 1 CUP, UNIT-DOSESYRUP108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1276-00ML - Milliliter0121-127685c39fa4-6419-4dec-9bae-36a45d499bda12017-12-14
0121-1276-10ML - Milliliter0121-1276e5a70701-5b1c-4cbb-b037-f9dcd4d92c6812017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTSGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1276GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 3 package rows20241113_ff970fff-d1a3-4322-83b4-34e361431a1c.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 51 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC869e950c-5861-4840-aaad-b0342790d62b2026-02-10WarningsExact identifier
application number: M012
CareOne Night TIme Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de252026-02-10WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Sportpharm LLCd61df3a4-8ae2-46b1-b322-7f4e04cc1bf92026-02-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIf3fc270a-92fc-46d5-b187-44e875c3abb92026-02-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incd07112dd-27df-46cc-b7c3-af8ba7601d062026-02-09WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC48f7933e-6582-638c-e063-6394a90abfe52026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRetail Business Services, LLC4fb46860-2bf9-41a7-89eb-31c259c611072026-02-06Warnings, Adverse reactionsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLSportpharm LLC909dacfa-50d3-4bcf-b2df-5405427cfaad2026-02-06WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf91b7c1f-e074-4767-b9c8-dbf1937a6a0f2026-02-06WarningsExact identifier
application number: M012
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
application number: M012
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPharmacy Value Alliance, LLCd836c3e2-3b69-41f3-b166-21270550e8ab2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPublix Super Markets, Inc.81b1d5bb-f813-4f79-9559-2494db33ad3c2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEKroger Company6499f854-2995-48cb-9c80-be6524b3db432026-02-05WarningsExact identifier
application number: M012
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact 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 SolutionPSNff970fff-d1a3-4322-83b4-34e361431a1c8
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDff970fff-d1a3-4322-83b4-34e361431a1c8
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYff970fff-d1a3-4322-83b4-34e361431a1c8
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYff970fff-d1a3-4322-83b4-34e361431a1c8
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYff970fff-d1a3-4322-83b4-34e361431a1c8
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed7
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed7
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed7
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed7
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1276-000012112760010 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10) 10 tray1992-07-010000-00-00NoNoCurrent
0121-1276-100012112761010 mL in 1 CUP, UNIT-DOSE10 mlHistorical