FDA.reportPublic FDA data

Theraflu Severe Cold Relief Daytime

Product NDC
70264-047
11-digit product format
702640047
Labeler code
70264
Product ID
70264-047_43c91d3a-f1f9-ffcd-e063-6294a90a7860
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
R J General Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-12
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
500; 20 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 Severe Cold Relief Daytime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 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
2670598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffcAvailable 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
70264-047-01Theraflu Severe Cold Relief Daytime25 in 1 CARTONPOWDER, FOR SOLUTION252
70264-047-01Theraflu Severe Cold Relief Daytime1 in 1 PACKETPOWDER, FOR SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-047THERAFLU SEVERE COLD RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) POWDER, FOR SOLUTION [R J GENERAL CORPORATION]1Current NDC, 2 package rows20241116_8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc.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 176 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC169006cb-7dc2-4113-a289-0b1f14e784b72023-10-23WarningsExact identifier
application number: M012
Night-Time Cold and Flu ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealthLife of USA2ffd62a6-703f-4cb0-bb13-49719c004d002023-10-21WarningsExact identifier
application number: M012
Day-Time Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHANHealthLife of USAc5f6cf22-2aaa-40e1-b7b3-448e55898d622023-10-21WarningsExact identifier
application number: M012
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAPNAR PHARMA LPe5004c10-3877-c199-e053-2a95a90aa8ac2023-10-21Boxed warning, WarningsExact identifier
application number: M012
Day and Night Multi Symptom Cold and Flu ReliefDAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEFIntrivo Diagnostics Inc.a311bf39-de6c-4ed5-949e-718ad8be1e492023-10-13WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion Cough Night Time Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0d65c4a9-938c-4a89-b1f1-d9ada8a8c5872023-10-10WarningsExact identifier
application number: M012
Triacting Daytime Cold Cough ChildrensDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8656aa2e-9546-4de4-9ecc-ce99bf9033332023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreensa33ae35b-1cde-4a3d-a836-3b169e4f1bb92023-10-10WarningsExact identifier
application number: M012
Severe Cold and Cough Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)553d01a9-e8ad-4797-b55b-32f134f08af92023-10-10WarningsExact identifier
application number: M012
Mucus Relief Maximum StrengthCold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens8781e2c5-ad46-4615-a0d9-879590e86f952023-10-10WarningsExact identifier
application number: M012
Mucus Relief All in One Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens419df833-1f33-45cf-bab3-730c928d58872023-10-10WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)93a5cb36-3262-4224-a5be-5ea1619a67bd2023-10-10WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINCVS Pharmacy782fb103-cd9f-4e8c-8f3a-1fb131b9eda62023-10-09WarningsExact identifier
application number: M012
Cold and Congestion Childrens NighttimeDIPHENHYDRAMINE HCI, PHENYLEPHRINE HCLWalgreensa7847413-e556-4f88-8a7f-a8528afbe9272023-10-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLC06d2c6cf-0adb-91b9-e063-6294a90aff522023-10-03WarningsExact identifier
application number: M012
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIXACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b2023-10-02WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.ac8c0c15-b305-47f2-8712-e4b53636f7fa2023-10-02WarningsExact identifier
application number: M012
Maximum strength Day cold and flu and Night severe cold and fluACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETSTIME CAP LABORATORIES,INCfff69901-965c-5372-e053-6394a90a29c22023-09-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionPSN8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSCD8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2
2670598APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSY8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70264-047-017026400470125 PACKET in 1 CARTON (70264-047-01) / 1 POWDER, FOR SOLUTION in 1 PACKET25 packet2024-11-12NoNoCurrent