FDA.reportPublic FDA data

Day-Time Cold and Flu Relief

Product NDC
69517-160
11-digit product format
695170160
Labeler code
69517
Product ID
69517-160_08337902-0be0-a579-e063-6294a90afc67
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine, Dextromethorphan
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HealthLife of USA
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-04
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
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
Day-Time Cold and Flu Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

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
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5f6cf22-2aaa-40e1-b7b3-448e55898d62Available 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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69517-160-10Day-Time Cold and Flu Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
69517-160-10Day-Time Cold and Flu Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-160DAY-TIME COLD AND FLU RELIEF (ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN) CAPSULE, LIQUID FILLED [HEALTHLIFE OF USA]2Current NDC, 2 package rows20231021_c5f6cf22-2aaa-40e1-b7b3-448e55898d62.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 37 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex Severe OriginalOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHcfd048c9-2f33-101d-e053-2995a90ad8542026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHd0768332-7c24-7c30-e053-2a95a90a26d42026-04-22WarningsExact identifier
application number: M012
HistanazPSEUDOEPHEDRINE HCL, PYRILAMINE MALEATECapital Pharmaceutical, LLC3e87d0f3-f16c-5972-e063-6294a90acc8a2026-04-22WarningsExact identifier
application number: M012
Good Sense Severe Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companyd5faf89f-3641-4be1-8d43-35504f12fe8d2026-04-22WarningsExact identifier
application number: M012
Multi-Symptom Cold childrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd42026-04-22WarningsExact identifier
application number: M012
good sense nasalOXYMETAZOLINE HYDROCHLORIDEL. Perrigo Company95f23049-e523-4c59-904c-b8e9ae82602c2026-04-22WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy NoseDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc07dad99-87b0-419b-9230-7c22a77ecf9e2026-04-21WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRValu Merchandisers Company83db90da-9155-4f6a-8209-44c87d14b6962026-04-21WarningsExact identifier
application number: M012
Pain, Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED613a2516-fc61-4bb4-bd44-ca60045481932026-04-21WarningsExact identifier
application number: M012
Dr. Simi Allergy ReliefDIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4fe8bbe3-13c9-5458-e063-6294a90a90642026-04-20WarningsExact identifier
application number: M012
Cold and Flu Day and Night, SevereACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE58d722ef-db67-44ac-a295-dd10e1f5ca1d2026-04-20WarningsExact identifier
application number: M012
Loratadine 10mgLORATADINEBETTER LIVING BRANDS, LLC46d615dd-45d5-2dfc-e063-6394a90a5d422026-04-18WarningsExact identifier
application number: M012
Multi-Symptom Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companyd0f896a6-5637-45ef-bf60-b343cbcdcf7e2026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsExact identifier
application number: M012
Multi-Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLValu Merchandisers Companybf3158af-89ab-4b7c-9f39-0f316fbe90562026-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsExact identifier
application number: M012
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNc5f6cf22-2aaa-40e1-b7b3-448e55898d622
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDc5f6cf22-2aaa-40e1-b7b3-448e55898d622
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYc5f6cf22-2aaa-40e1-b7b3-448e55898d622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69517-160-10695170160101 BLISTER PACK in 1 CARTON (69517-160-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2023-04-04NoNoCurrent