Theraflu-D Flu Relief Max Strength plus Nasal Decongestant

Product NDC
0067-0114
11-digit product format
000670114
Labeler code
0067
Product ID
0067-0114_178e716d-ce9d-a6ca-e063-6294a90a4371
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Pseudoephedrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-19
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1000; 4; 30; 60 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-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-D Flu Relief Max Strength plus Nasal Decongestant
Brand name suffix
Nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
CHLORPHENIRAMINE MALEATE4 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 6V9V2RYJ8N
Rxcui2049283

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0114-01Theraflu-D Flu Relief Max Strength plus Nasal DecongestantNighttime237 mL in 1 BOTTLESYRUP2371
0067-0114-01Theraflu-D Flu Relief Max Strength plus Nasal DecongestantNighttime1 in 1 CARTONSYRUP11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-0114-01ML - Milliliter0067-0114b2947550-702f-4815-98fc-5622d08b7f5912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0114THERAFLU-D FLU RELIEF MAX STRENGTH PLUS NASAL DECONGESTANT NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL) SYRUP [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240619_09e20842-2b75-43b9-ae5f-3515b35e655b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049283acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / pseudoephedrine HCl 60 MG in 30 mL Oral SolutionPSN09e20842-2b75-43b9-ae5f-3515b35e655b1
2049283acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML / pseudoephedrine hydrochloride 2 MG/ML Oral SolutionSCD09e20842-2b75-43b9-ae5f-3515b35e655b1
2049283acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / pseudoephedrine HCl 60 MG per 30 ML Oral SolutionSY09e20842-2b75-43b9-ae5f-3515b35e655b1
2049283APAP 33.3 MG/ML / Chlorpheniramine Maleate 0.133 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Pseudoephedrine Hydrochloride 2 MG/ML Oral SolutionSY09e20842-2b75-43b9-ae5f-3515b35e655b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-0114-01000670114011 BOTTLE in 1 CARTON (0067-0114-01) / 237 mL in 1 BOTTLE1 bottle2024-06-19NoNoHistorical