FDA.reportPublic FDA data

Cold and Flu Relief

Product NDC
37808-848
11-digit product format
378080848
Labeler code
37808
Product ID
37808-848_aafc94d6-ec5c-4075-9e39-2729d6f89218
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-30
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
Cold and Flu Relief
Brand name suffix
Daytime
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
bd19b1f2-d9d3-4dab-8181-605f769ab62fAvailable 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
37808-848-16Cold and Flu ReliefDaytime16 in 1 CARTONCAPSULE, LIQUID FILLED163
37808-848-16Cold and Flu ReliefDaytime1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-848COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [H E B]3Current NDC, Legacy NDC, 2 package rows20240410_bd19b1f2-d9d3-4dab-8181-605f769ab62f.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 166 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGood Sensebb709377-7bb3-4931-a2b6-2443aee07c122024-01-26WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
application number: M012
Sugar Free Cough Drops Honey LemonMENTHOLCardinal Health 110, Inc.fe90dc33-2815-8296-e053-6294a90ac1df2024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCardinal Health 110, Inc.fe91543e-a798-6399-e053-6394a90af5e52024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough Drops Black CherryMENTHOLCardinal Health 110, Inc.fe90cf63-d286-fa5e-e053-6394a90a77592024-01-19WarningsExact identifier
application number: M012
Cough Drops Menthol Honey LemonCOUGH DROPS MENTHOLCardinal Health 110, Inc.fe5b3f6d-2a2d-f322-e053-6394a90aba042024-01-19WarningsExact identifier
application number: M012
Cough Drops MentholMENTHOL COUGH DROPSCardinal Health 110, Inc.fe5b557e-a689-a32c-e053-6294a90aadbd2024-01-19WarningsExact identifier
application number: M012
Cough Drops CherryCHERRY FLAVOR COUGH DROPSCardinal Health 110, Inc.fe5b5e57-1368-c62b-e053-6294a90ae82c2024-01-19WarningsExact identifier
application number: M012
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
application number: M012
Cough and Congestion DM Sugar FreeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBest Choice (Valu Merchandisers Company)4656e60e-4733-45c1-bf55-d156e45085c62024-01-17WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLRugby Laboratories775f97c0-6f82-49a8-82ac-f1a73920c3ec2024-01-11WarningsExact identifier
application number: M012
SinuFrin NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Incf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae2024-01-11WarningsExact identifier
application number: M012
SinuFrin Plus NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals, Inc.99afe6a6-1350-49c6-9347-b7e531e359252024-01-11WarningsExact identifier
application number: M012
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leaderad437177-08eb-4811-883f-ac543d5bc58c2024-01-11WarningsExact identifier
application number: M012
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact 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 CapsulePSNbd19b1f2-d9d3-4dab-8181-605f769ab62f3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDbd19b1f2-d9d3-4dab-8181-605f769ab62f3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYbd19b1f2-d9d3-4dab-8181-605f769ab62f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-848-163780808481616 BLISTER PACK in 1 CARTON (37808-848-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK16 blister pack2020-06-300000-00-00NoNoCurrent