FDA.reportPublic FDA data

Flu HBP

Product NDC
11822-0738
11-digit product format
118220738
Labeler code
11822
Product ID
11822-0738_181e2c2f-c4f6-463d-bb16-3dcec35418c9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-24
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
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

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
f1a4ee57-33a3-4791-a769-b208b38acb72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0738-8Flu HBPMaximum Strength2 in 1 CARTONTABLET, FILM COATED28
11822-0738-8Flu HBPMaximum Strength12 in 1 BLISTER PACKTABLET, FILM COATED128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0738FLU HBP MAXIMUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [RITE AID CORPORATION]7Current NDC, Legacy NDC, 2 package rows20240704_f1a4ee57-33a3-4791-a769-b208b38acb72.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 23 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Congestion Relief Cooling Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC90125a19-eed7-4ca4-a6dc-f38026c74d542026-06-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company54254b61-7861-4eeb-bd3c-54fd5266f4a72026-06-08WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION47a218a0-6395-36bd-e063-6394a90a265a2026-06-05WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLTARGET CORPORATION4779288a-9850-8490-e063-6394a90abe512026-06-05WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.b0d38db9-22a9-4dd8-8e0f-dd81805e724b2026-06-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY65d4d7ea-c080-404e-9836-7d6bdcc5ea7d2026-06-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe9d6a6e-38a1-44ae-a30f-596c5ec7d0572026-06-03WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyb0c1d635-0f85-433a-b479-51c68d259faa2026-06-03WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICEdc0a3761-bbe2-4261-a183-594f5fb12b0b2026-06-03WarningsExact identifier
application number: M012
Cold and Flu Daytime, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.f278cc81-65b2-4e45-be5b-41152cbb67c42026-06-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Inc358ba91d-06a4-49c9-994d-4e4bf9499dcd2026-06-03WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLCc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed2026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
application number: M012
Topcare Day Time Nite Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCaed387e0-5a8b-4caf-a373-3e04496a49832026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact 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 TabletPSNf1a4ee57-33a3-4791-a769-b208b38acb728
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCDf1a4ee57-33a3-4791-a769-b208b38acb728
2049841acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG Oral TabletSYf1a4ee57-33a3-4791-a769-b208b38acb728
2049841APAP 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG Oral TabletSYf1a4ee57-33a3-4791-a769-b208b38acb728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0738-8118220738082 BLISTER PACK in 1 CARTON (11822-0738-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-07-240000-00-00NoNoCurrent