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 44 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacyeafd9823-c0ad-454a-b725-562d88ebec922026-03-23WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)f288eeca-9803-4962-a802-fe34f5983c7a2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6e7dfee1-3de9-46c8-9b58-83fcf8ee72e02026-03-23WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
application number: M012
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4d88180f-610c-d9ab-e063-6394a90a09f02026-03-21WarningsExact identifier
application number: M012
Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inccc371bc3-ba7a-430d-9ee4-22e9c50935f12026-03-20WarningsExact identifier
application number: M012
Daytime Nighttime Multi Symptom Cold ChildrensDEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreensda4c36f5-ec79-4489-bb18-8ddab79c34bd2026-03-20WarningsExact identifier
application number: M012
Sanatos DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEPharmadel LLC3bddcd5a-7776-49ff-e063-6294a90a5dd12026-03-20WarningsExact identifier
application number: M012
VaporizingCAMPHORAmazon.com Services LLC21cfe9cb-5ff5-4331-8358-4d1d9646d6ac2026-03-19Warnings, Adverse reactionsExact identifier
application number: M012
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact 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