FDA.reportPublic FDA data

Cough and Cold HBP

Product NDC
50844-689
11-digit product format
508440689
Labeler code
50844
Product ID
50844-689_eda8099c-cbbf-4aa3-9142-fbb7a700901b
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-15
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
4; 30 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
2026-12-31
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
Cough and Cold HBP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
1421985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f2daffc-1904-4d64-9f84-689c88601e06Available 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
50844-689-21Cough and Cold HBP2 in 1 CARTONTABLET, FILM COATED212
50844-689-21Cough and Cold HBP8 in 1 BLISTER PACKTABLET, FILM COATED812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-689COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]10Current NDC, Legacy NDC, 2 package rows20240921_9f2daffc-1904-4d64-9f84-689c88601e06.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 44 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacyeafd9823-c0ad-454a-b725-562d88ebec922026-03-23WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)f288eeca-9803-4962-a802-fe34f5983c7a2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
application number: M012
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6e7dfee1-3de9-46c8-9b58-83fcf8ee72e02026-03-23WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESINHyvee Inc44eafc83-8e7b-89b8-e063-6394a90ab0bc2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
application number: M012
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
application number: M012
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4d88180f-610c-d9ab-e063-6394a90a09f02026-03-21WarningsExact identifier
application number: M012
Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inccc371bc3-ba7a-430d-9ee4-22e9c50935f12026-03-20WarningsExact identifier
application number: M012
Daytime Nighttime Multi Symptom Cold ChildrensDEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreensda4c36f5-ec79-4489-bb18-8ddab79c34bd2026-03-20WarningsExact identifier
application number: M012
Sanatos DaytimeACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEPharmadel LLC3bddcd5a-7776-49ff-e063-6294a90a5dd12026-03-20WarningsExact identifier
application number: M012
VaporizingCAMPHORAmazon.com Services LLC21cfe9cb-5ff5-4331-8358-4d1d9646d6ac2026-03-19Warnings, Adverse reactionsExact identifier
application number: M012
Equate Wild Cherry Throat DropPECTINWalmart4d66547a-b72a-a0ac-e063-6394a90adc712026-03-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATESafeway, Inc.45d44cd2-5187-4a5c-983a-edb1e8eba0b22026-03-19WarningsExact identifier
application number: M012
Sedalmex XL FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBelmora LLCf2edfedf-e06e-4d1b-8c2d-732e08ec113c2026-03-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421985chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG Oral TabletPSN9f2daffc-1904-4d64-9f84-689c88601e0612
1421985chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG Oral TabletSCD9f2daffc-1904-4d64-9f84-689c88601e0612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-689-21508440689212 BLISTER PACK in 1 CARTON (50844-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2017-05-150000-00-00NoNoCurrent