FDA.reportPublic FDA data

Theraflu

Product NDC
0067-0111
11-digit product format
000670111
Labeler code
0067
Product ID
0067-0111_91dbb541-6a86-4803-a1fe-1bf61b457c34
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-19
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 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
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
Theraflu
Brand name suffix
Severe Cold Relief Soft Chews
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2685209Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91dbb541-6a86-4803-a1fe-1bf61b457c34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0111-01TherafluSevere Cold Relief Soft Chews20 in 1 BOTTLETABLET, CHEWABLE201
0067-0111-02TherafluSevere Cold Relief Soft Chews10 in 1 BOTTLETABLET, CHEWABLE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0111THERAFLU SEVERE COLD RELIEF SOFT CHEWS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240619_91dbb541-6a86-4803-a1fe-1bf61b457c34.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 125 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
application number: M012
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
application number: M012
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, EqualineLEVMETAMFETAMINESupervalu Inc.44f72f34-d0b8-421f-b240-86286de874cf2024-12-20WarningsExact identifier
application number: M012
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685209acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Chewable TabletPSN91dbb541-6a86-4803-a1fe-1bf61b457c341
2685209acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Chewable TabletSCD91dbb541-6a86-4803-a1fe-1bf61b457c341
2685209APAP 325 MG / dextromethorphan hydrobromide 10 MG Chewable TabletSY91dbb541-6a86-4803-a1fe-1bf61b457c341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0067-0111-010006701110120 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01) 2024-06-19NoNoCurrent
0067-0111-020006701110210 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02) 2024-06-19NoNoCurrent