FDA.reportPublic FDA data

Flu HBP

Product NDC
63868-567
11-digit product format
638680567
Labeler code
63868
Product ID
63868-567_1cd78d42-255e-43e2-bf72-8f4bf2676e5a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-25
Marketing end
2027-11-30
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 2; 10 mg/1; mg/1; mg/1
Pharmacologic classes
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]
NDC exclude flag
No
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
Flu HBP
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal 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
2049841Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d1b3418-85a8-4ca0-bca7-261b2b58032aAvailable 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
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
63868-567-20Flu HBPMaximum Strength10 in 1 BLISTER PACKTABLET, FILM COATED109
63868-567-20Flu HBPMaximum Strength2 in 1 CARTONTABLET, FILM COATED29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-567-20EA - Each63868-5671849e671-8ee6-417b-be51-c5af3160533c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-567FLU HBP MAXIMUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]7Current NDC, Legacy NDC, 2 package rows20240825_7d1b3418-85a8-4ca0-bca7-261b2b58032a.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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG Oral TabletPSN7d1b3418-85a8-4ca0-bca7-261b2b58032a9
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD7d1b3418-85a8-4ca0-bca7-261b2b58032a9
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG Oral TabletSY7d1b3418-85a8-4ca0-bca7-261b2b58032a9
2049841APAP 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG Oral TabletSY7d1b3418-85a8-4ca0-bca7-261b2b58032a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-567-20638680567202 BLISTER PACK in 1 CARTON (63868-567-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-03-252027-11-30NoNoCurrent