FDA.reportPublic FDA data

Theraflu

Product NDC
0067-6094
11-digit product format
000676094
Labeler code
0067
Product ID
0067-6094_132d9efd-0e0c-a2c7-e063-6294a90a1fe1
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-28
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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

Additional Listing Data#

Finished product
Yes
Brand name base
Theraflu
Brand name suffix
PowerPods Daytime Severe Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1659967

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6094-01TherafluPowerPods Daytime Severe Cold8 in 1 CARTONPOWDER, FOR SOLUTION87
0067-6094-02TherafluPowerPods Daytime Severe Cold1 in 1 POUCHPOWDER, FOR SOLUTION17
0067-6094-03TherafluPowerPods Daytime Severe Cold1 in 1 CARTONPOWDER, FOR SOLUTION17
0067-6094-03TherafluPowerPods Daytime Severe Cold1 in 1 POUCHPOWDER, FOR SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6094-01EA - Each0067-60944afd9b5c-37b7-4a89-9a52-6cff618c43b112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6094THERAFLU POWERPODS DAYTIME SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240310_e655c33c-c319-41d9-ae55-cf747242cd10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNe655c33c-c319-41d9-ae55-cf747242cd107
1659967acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDe655c33c-c319-41d9-ae55-cf747242cd107
1659967acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral SolutionSYe655c33c-c319-41d9-ae55-cf747242cd107
1659967APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYe655c33c-c319-41d9-ae55-cf747242cd107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-6094-01000676094018 POUCH in 1 CARTON (0067-6094-01) / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6094-02) 8 pouch2018-07-280000-00-00NoNoCurrent
0067-6094-02000676094021 in 1 POUCHHistorical
0067-6094-03000676094031 POUCH in 1 CARTON (0067-6094-03) / 1 POWDER, FOR SOLUTION in 1 POUCH1 pouch2019-01-200000-00-00NoNoCurrent