FDA.reportPublic FDA data

Theraflu Flu Relief Max Strength

Product NDC
0067-7921
11-digit product format
000677921
Labeler code
0067
Product ID
0067-7921_35339df5-9ec8-6a29-e063-6294a90acbb9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr
Dosage form
POWDER
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1000; 30 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

Additional Listing Data#

Finished product
Yes
Brand name base
Theraflu Flu Relief Max Strength
Brand name suffix
Daytime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/1
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH
Rxcui2636656

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-7921-02Theraflu Flu Relief Max StrengthDaytime Nighttime Combo Pack6 in 1 CARTONPOWDER630 mg5
0067-7921-02Theraflu Flu Relief Max StrengthDaytime6 in 1 CARTONPOWDER63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-7921-02EA - Each0067-792124e2c547-7edc-4510-9afd-86d599347b7612025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-7921THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]5Current NDC20250521_812a093f-cf83-4f7a-927a-1b5695be7f90.zip
0067-7921THERAFLU FLU RELIEF MAX STRENGTH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) POWDER [HALEON US HOLDINGS LLC]3Current NDC, 1 package rows20250519_a1405038-80f2-45e5-bd8c-8c6b0ee348be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2636659{1 (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackGPCK812a093f-cf83-4f7a-927a-1b5695be7f905
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral Solution) } PackPSN812a093f-cf83-4f7a-927a-1b5695be7f905
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Powder for Oral SolutionPSN812a093f-cf83-4f7a-927a-1b5695be7f905
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionPSN812a093f-cf83-4f7a-927a-1b5695be7f905
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD812a093f-cf83-4f7a-927a-1b5695be7f905
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCD812a093f-cf83-4f7a-927a-1b5695be7f905
2636659{1 daytime (acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral Solution) } PackSY812a093f-cf83-4f7a-927a-1b5695be7f905
2636658acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY812a093f-cf83-4f7a-927a-1b5695be7f905
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSY812a093f-cf83-4f7a-927a-1b5695be7f905
2636658APAP 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY812a093f-cf83-4f7a-927a-1b5695be7f905
2636656APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSY812a093f-cf83-4f7a-927a-1b5695be7f905
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionPSNa1405038-80f2-45e5-bd8c-8c6b0ee348be3
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSCDa1405038-80f2-45e5-bd8c-8c6b0ee348be3
2636656acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG Granules for Oral SolutionSYa1405038-80f2-45e5-bd8c-8c6b0ee348be3
2636656APAP 1000 MG / dextromethorphan hydrobromide 30 MG Powder for Oral SolutionSYa1405038-80f2-45e5-bd8c-8c6b0ee348be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-7921-02000677921026 POWDER in 1 CARTON (0067-7921-02) 6 powder2022-06-15NoNoCurrent