Multi-Symptom Cold Relief

Product NDC
47682-047
11-digit product format
476820047
Labeler code
47682
Product ID
47682-047_3e4c8eb0-708e-774b-e063-6294a90a8436
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 100; 325; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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
Multi-Symptom Cold Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN100 mg/1
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
362O9ITL9DInternal 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
1098435Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e6ea6faf-baff-a130-e053-2a95a90a085aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-047-47Multi-Symptom Cold Relief100 in 1 BOXTABLET, FILM COATED1006
47682-047-80Multi-Symptom Cold Relief40 in 1 BOXTABLET, FILM COATED406
47682-047-99Multi-Symptom Cold Relief2 in 1 PACKETTABLET, FILM COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-047MULTI-SYMPTOM COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]5Current NDC, Legacy NDC, 3 package rows20250210_e6ea6faf-baff-a130-e053-2a95a90a085a.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 131 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012
CVS Vapor SteamCAMPHOR (SYNTHETIC)CVS49da2c40-afc5-5770-e054-00144ff88e882024-12-13WarningsExact identifier
application number: M012
Kroger Daytime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Companye428dd83-c538-2a92-e053-2a95a90a0e162024-12-13WarningsExact identifier
application number: M012
Kroger Nighttime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
application number: M012
Foster and Thrive Childrens Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC7eaba464-5cdb-4bd4-b272-38fa108658d52024-12-13WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe OriginalOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC1d089074-3969-ce6e-e063-6294a90aa70c2024-12-12WarningsExact identifier
application number: M012
RIGHT REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Incb4fc014c-7c5f-46a4-bf13-57103b6fa0182024-12-11WarningsExact identifier
application number: M012
Diphenhydramine Hydrochloride 25mgDIPHENHYDRAMINE HYDROCHLORIDE 25MGStrive Pharmaceuticals Incb440eb2e-4de9-2b65-e053-2995a90abda82024-12-11WarningsExact identifier
application number: M012
Meijer Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.6933ca9d-a32d-d856-e053-2a91aa0a408e2024-12-10WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.826b5c0d-7a75-bbf0-e053-2a91aa0aebd62024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.09141018-37ba-4c93-9051-1ed129c448c12024-12-10WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola USA Inc.6ac9d95b-f6b9-4515-b126-697f8f8396122024-12-10WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola USA Inc.989d1529-2875-47bf-81df-65494d62be7a2024-12-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098435acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral TabletPSNe6ea6faf-baff-a130-e053-2a95a90a085a6
1098435acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe6ea6faf-baff-a130-e053-2a95a90a085a6
1098435APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe6ea6faf-baff-a130-e053-2a95a90a085a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-047-4747682004747100 PACKET in 1 BOX (47682-047-47) / 2 TABLET, FILM COATED in 1 PACKET (47682-047-99) 100 packet2022-09-26NoNoCurrent
47682-047-804768200478040 PACKET in 1 BOX (47682-047-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-047-99) 40 packet2022-09-260000-00-00NoNoCurrent
47682-047-99476820047992 TABLET, FILM COATED in 1 PACKET (47682-047-99) 2022-09-26NoNoCurrent