FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
66715-6931
11-digit product format
667156931
Labeler code
66715
Product ID
66715-6931_4522e7fd-f72b-080c-e063-6294a90a6565
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Lil' Drug Store Products, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Daytime Cold and Flu
Brand name suffix
Lil Drug Store Products
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

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
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1113705Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd5c20ed-5520-4db0-bfd4-995f043af2a4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6931-4Daytime Cold and FluLil Drug Store Products237 mL in 1 BOTTLE, PLASTICLIQUID2377

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
AcetaminophenACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
DextromethorphanACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
PhenylephrineACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
SucroseINACTIVE INGREDIENTC151H8M554DAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1
WaterINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6931DAYTIME COLD AND FLU LIL DRUG STORE PRODUCTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LIL' DRUG STORE PRODUCTS, INC]5Current NDC, Legacy NDC, 1 package rows20250101_fd5c20ed-5520-4db0-bfd4-995f043af2a4.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 53 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amazon Basics Honey Lemon Cough Drops 30ctMENTHOLAmazon3e75838b-e1c9-2d42-e063-6294a90aab822026-02-01WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc5110526f-51fd-401e-ba52-520674d34f372026-02-01WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLAmazon.com Service LLC673996ab-6e57-4feb-8af3-d8b474741a8d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services, LLC1d6c23d7-d1dc-4cba-8600-5762c18a0e272026-01-29WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBelmora LLC3622e072-2784-c57e-e063-6394a90a82172026-01-29Warnings, Adverse reactionsExact identifier
application number: M012
Night Time Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLCe7dd763b-3005-4723-933b-171eb772afee2026-01-29WarningsExact identifier
application number: M012
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBrACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd24bc9ae6-8e8f-c0a0-e063-6394a90a407f2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited229d1939-84a9-f18e-e063-6394a90aba302026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1fcbafaa-c871-db6d-e063-6394a90aab5e2026-01-28WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1f7a6375-ab66-9782-e063-6394a90a99f32026-01-28WarningsExact identifier
application number: M012
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.4970b8bc-3c7b-4b8a-e063-6294a90a7f1b2026-01-28WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
application number: M012
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc53a3e6a7-d625-4393-95eb-bb6f86e86cc12026-01-27WarningsExact identifier
application number: M012
Dextromethorphan Hbr,GuaifenesinDEXTROMETHORPHAN HBR,GUAIFENESINSOFTGEL HEALTHCARE PRIVATE LIMITED2fbbfc7c-81a9-b647-e063-6394a90a55ac2026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED32074a31-326b-4aaf-e063-6394a90a0d402026-01-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED335b6ddd-fdc8-1120-e063-6394a90add412026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATESOFTGEL HEALTHCARE PRIVATE LIMITED2f7f078e-de04-9d53-e063-6394a90a409f2026-01-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNfd5c20ed-5520-4db0-bfd4-995f043af2a47
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDfd5c20ed-5520-4db0-bfd4-995f043af2a47
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYfd5c20ed-5520-4db0-bfd4-995f043af2a47
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYfd5c20ed-5520-4db0-bfd4-995f043af2a47
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYfd5c20ed-5520-4db0-bfd4-995f043af2a47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-6931-466715693104237 mL in 1 BOTTLE, PLASTIC (66715-6931-4) 237 ml2016-04-150000-00-00NoNoCurrent