FDA.reportPublic FDA data

MUCINEX INSTASOOTHE

Product NDC
72854-263
11-digit product format
728540263
Labeler code
72854
Product ID
72854-263_5a5f2710-9a16-e17c-e063-6294a90af062
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE and HEXYLRESORCINOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; HEXYLRESORCINOL
Active strength
5; 2 mg/1; mg/1
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
MUCINEX INSTASOOTHE
Brand name suffix
SORE THROAT PLUS COUGH RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/1
HEXYLRESORCINOL2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
R9QTB5E82NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2566823Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d670d91-9e22-45b9-b568-5b62c2133d32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-263-20MUCINEX INSTASOOTHESORE THROAT PLUS COUGH RELIEF20 in 1 BAGLOZENGE205
72854-263-20MUCINEX INSTASOOTHESORE THROAT PLUS COUGH RELIEF1 in 1 POUCHLOZENGE15
72854-263-40MUCINEX INSTASOOTHESORE THROAT PLUS COUGH RELIEF1 in 1 POUCHLOZENGE15
72854-263-40MUCINEX INSTASOOTHESORE THROAT PLUS COUGH RELIEF40 in 1 BAGLOZENGE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-263-20EA - Each72854-26398c1a2e9-942a-4b77-8d28-835d7553323012021-09-07
72854-263-40EA - Each72854-2639e51bfe4-8dba-4f7e-9c61-a652824542ca12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-263MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL) LOZENGE [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 4 package rows20250410_8d670d91-9e22-45b9-b568-5b62c2133d32.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 53 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
application number: M012
Foster and Thrive Honey Lemon Cough DropsMENTHOLMcKesson49f13ee3-6bb3-e500-e063-6394a90a152d2026-02-03WarningsExact identifier
application number: M012
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
application number: M012
Foster and Thrive SF Honey Lemon Cough DropsMENTHOLMcKesson49f41c30-f806-44ba-e063-6394a90a5a672026-02-03WarningsExact identifier
application number: M012
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
application number: M012
allergy reliefDIPHENHYDRAMINE HCLMeijer Distribution Inc7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f2026-02-03WarningsExact identifier
application number: M012
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
application number: M012
tussin dm nighttime maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Inc1f3fb451-84c9-432e-ac67-2694dd66c8152026-02-03WarningsExact identifier
application number: M012
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company6b0d261f-fc27-4b34-88b1-cd3d727667602026-02-02WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leaderebfcb699-3369-4697-9841-44015b1c98082026-02-02WarningsExact identifier
application number: M012
Cherry Sore Throat LozengesBENZOCAINE, MENTHOLMeijer Distribution Inc.2f6de590-7cad-25d7-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
application number: M012
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
application number: M012
Amazon Basics Cherry Cough Drops 30ctMENTHOLAmazon3e74e209-c9c9-3979-e063-6294a90afcfa2026-02-01WarningsExact identifier
application number: M012
Amazon Basics Honey Lemon Cough Drops 30ctMENTHOLAmazon3e75838b-e1c9-2d42-e063-6294a90aab822026-02-01WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc5110526f-51fd-401e-ba52-520674d34f372026-02-01WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLAmazon.com Service LLC673996ab-6e57-4feb-8af3-d8b474741a8d2026-01-30Warnings, Adverse reactionsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2566823dextromethorphan hydrobromide 5 MG / hexylresorcinol 2 MG Oral LozengePSN8d670d91-9e22-45b9-b568-5b62c2133d325
2566823dextromethorphan hydrobromide 5 MG / hexylresorcinol 2 MG Oral LozengeSCD8d670d91-9e22-45b9-b568-5b62c2133d325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-263-207285402632020 POUCH in 1 BAG (72854-263-20) / 1 LOZENGE in 1 POUCH20 pouch2021-07-010000-00-00NoNoCurrent
72854-263-407285402634040 POUCH in 1 BAG (72854-263-40) / 1 LOZENGE in 1 POUCH40 pouch2021-07-010000-00-00NoNoCurrent