FDA.reportPublic FDA data

Cold and Flu

Product NDC
0363-8063
11-digit product format
003638063
Labeler code
0363
Product ID
0363-8063_8153adea-6191-4251-9fc3-dfc8c3adb8b6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-23
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
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
2027-12-31
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
Cold and Flu
Brand name suffix
Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
TRIPROLIDINE HYDROCHLORIDE2.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2173667Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de4e8af4-d3d0-44b3-aea3-79016803ccdcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8063-45Cold and FluNighttime177 mL in 1 BOTTLE, PLASTICSOLUTION1774
0363-8063-45Severe Congestion and Cough, Cold and FluNighttime177 mL in 1 BOTTLE, PLASTICSOLUTION177 mL20 mg in 20mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8063COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALGREEN COMPANY]2Current NDC, 1 package rows20241023_de4e8af4-d3d0-44b3-aea3-79016803ccdc.zip
0363-8063SEVERE CONGESTION AND COUGH, COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREEN COMPANY]2Current NDC20241017_b75af815-9bd4-4a7a-bc68-f42f4af50699.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 44 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacyeafd9823-c0ad-454a-b725-562d88ebec922026-03-23WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)f288eeca-9803-4962-a802-fe34f5983c7a2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6e7dfee1-3de9-46c8-9b58-83fcf8ee72e02026-03-23WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
application number: M012
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4d88180f-610c-d9ab-e063-6394a90a09f02026-03-21WarningsExact identifier
application number: M012
Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inccc371bc3-ba7a-430d-9ee4-22e9c50935f12026-03-20WarningsExact identifier
application number: M012
Daytime Nighttime Multi Symptom Cold ChildrensDEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreensda4c36f5-ec79-4489-bb18-8ddab79c34bd2026-03-20WarningsExact identifier
application number: M012
Sanatos DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEPharmadel LLC3bddcd5a-7776-49ff-e063-6294a90a5dd12026-03-20WarningsExact identifier
application number: M012
VaporizingCAMPHORAmazon.com Services LLC21cfe9cb-5ff5-4331-8358-4d1d9646d6ac2026-03-19Warnings, Adverse reactionsExact identifier
application number: M012
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2390630{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCKb75af815-9bd4-4a7a-bc68-f42f4af506994
23906301 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSNb75af815-9bd4-4a7a-bc68-f42f4af506994
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSNb75af815-9bd4-4a7a-bc68-f42f4af506994
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNb75af815-9bd4-4a7a-bc68-f42f4af506994
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCDb75af815-9bd4-4a7a-bc68-f42f4af506994
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDb75af815-9bd4-4a7a-bc68-f42f4af506994
23906301 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSYb75af815-9bd4-4a7a-bc68-f42f4af506994
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSYb75af815-9bd4-4a7a-bc68-f42f4af506994
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSYb75af815-9bd4-4a7a-bc68-f42f4af506994
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYb75af815-9bd4-4a7a-bc68-f42f4af506994
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYb75af815-9bd4-4a7a-bc68-f42f4af506994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-8063-4500363806345177 mL in 1 BOTTLE, PLASTIC (0363-8063-45) 177 ml2023-10-23NoNoCurrent