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 103 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson Sugar Free Cough Suppressant Oral AnestheticMENTHOL LOZENGEMcKesson Medical-Surgicale0dfa6ca-b311-25cb-e053-2a95a90a12cc2025-09-09WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione648f017-9e30-df6c-e053-2995a90adcd02025-09-09WarningsExact identifier
application number: M012
Medi-First Honey Lemon Cough DropsMENTHOL 8.6 MGUnifirst First Aid Corporation826e1b87-e5a9-8637-e053-2991aa0aded12025-09-09WarningsExact identifier
application number: M012
Unishield Cherry CoughMENTHOLUnishieldb8297bc1-44b2-3de0-e053-2995a90ad01b2025-09-09WarningsExact identifier
application number: M012
McKesson Cough SupressantMENTHOLMcKesson Medical-Surgicaldb5e0490-2ed8-2d53-e053-2a95a90a98f52025-09-09WarningsExact identifier
application number: M012
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
application number: M012
Rompe Pecho CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLEfficient Laboratories Inc96c4dee1-6e66-4442-a7e3-56e874414c172025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc57c458ed-7987-453b-ab24-bbfa6580f9202025-09-09WarningsExact identifier
application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.38637189-d1ee-9405-e063-6394a90ae8b82025-09-09WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreensfd52d8d8-7cd1-4e92-86da-354a1d5213c22025-09-08WarningsExact identifier
application number: M012
Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione8e5fb21-a7fd-44d1-b9c4-83e949699ca62025-09-08WarningsExact identifier
application number: M012
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
application number: M012
Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationf196f2c5-a100-42b1-bd01-0327b223838e2025-09-08WarningsExact identifier
application number: M012
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
application number: M012
Green Guard Allergy 2 ReliefPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation16fddca9-a66b-41e6-9423-eaf091d3971e2025-09-08WarningsExact identifier
application number: M012
Medique Medi-PhenylPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporationd7d62ac1-1333-4366-884b-26537766ce382025-09-08WarningsExact identifier
application number: M012
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
application number: M012
McKesson Sinus Pain and Pressure ReliefACETAMINOPHEN, PHENYLEPHRINE HCLMcKesson Medical-Surgicale0cbb213-4f4f-4045-e053-2a95a90a2a182025-09-08WarningsExact identifier
application number: M012
Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation1f172d58-4050-424b-9743-130d8e618fe82025-09-08WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Unifirst First Aid Corporatione8059137-efba-398c-e053-2a95a90a21f22025-09-08WarningsExact 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