FDA.reportPublic FDA data

Multi-Symptom Cold Relief

Product NDC
47682-047
Requested package NDC
47682-047-99
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 99 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC3314b174-d5bb-4843-9288-9b9c5fce79d52025-10-08WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
application number: M012
Giltuss DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc3f64c81a-bbfc-4575-e063-6294a90a6ed72025-10-06WarningsExact identifier
application number: M012
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
application number: M012
RoboHBr Cough SUPPRESSANTDEXTROMETHORPHAN HBRDXM Pharmaceutical, Inc0af624ce-191f-45e1-882b-e8acb90cc77b2025-10-06WarningsExact identifier
application number: M012
RoboTabletsDEXTROMETHORPHANDXM Pharmaceutical, Incb92cf698-032d-4d8d-b19c-456c6338b0942025-10-06WarningsExact identifier
application number: M012
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
application number: M012
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
application number: M012
Guaifenesin 400GUAIFENESIN TABLETS 400InvaTech Pharma Solutions LLC40291505-55ca-0759-e063-6394a90acee12025-10-02Exact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3dd5b783-5b64-24b5-e063-6394a90ab4ee2025-10-02WarningsExact identifier
application number: M012
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
application number: M012
Equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEUnited Natural Foods, Inc. dba UNFI3053f6d7-0eff-488c-8901-770dcc62af062025-10-02WarningsExact identifier
application number: M012
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact 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 formatDescriptionMarketing startSampleExclude flagStatus
47682-047-99476820047992 TABLET, FILM COATED in 1 PACKET (47682-047-99) 2022-09-26NoNoCurrent