NDC 42192-607-05 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42192-607
Requested NDC
42192-607-05
Package NDCs from labels
42192-607-05, 42192-607-40, 42192-607-04, 42192-607-16
Manufacturer
Acella Pharmaceuticals, LLC
Effective date
2026-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FD&C RED NO. 40 - Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC2026-03-16HUMAN PRESCRIPTION DRUG LABEL
ANHYDROUS CITRIC ACID - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-03-11HUMAN PRESCRIPTION DRUG LABEL
ANHYDROUS CITRIC ACID - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-01-12HUMAN PRESCRIPTION DRUG LABEL
ANHYDROUS CITRIC ACID - Proficient Rx LPProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-607-04Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide118 mL in 1 BOTTLE, PLASTICSYRUP11810
42192-607-05Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide5 mL in 1 CUP, UNIT-DOSESYRUP510
42192-607-16Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSYRUP47310
42192-607-40Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide40 in 1 CASESYRUP4010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-607BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [ACELLA PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 4 package rows20241004_1045e307-f60d-482d-8e06-40e72b84c651.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-607-04ML - Milliliter42192-6073d26921b-3f0a-49f4-8308-b375e8e641ef12016-11-08
42192-607-05ML - Milliliter42192-607c3977d1c-c98c-459c-ac52-2217cb42b6c612021-12-08
42192-607-16ML - Milliliter42192-6078212cb92-4d06-46e6-ac3c-51075bf7be9212016-11-08

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 1 of 145 · 2,888 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
unii: 9D2RTI9KYH
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: 6V9V2RYJ8N
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
unii: 9D2RTI9KYH
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
unii: 9D2RTI9KYH
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories8090d561-0478-435d-ad6f-2334e1823bc32026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
unii: 6V9V2RYJ8N
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 9D2RTI9KYH
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
unii: 9D2RTI9KYH
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
unii: 9D2RTI9KYH
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
unii: 9D2RTI9KYH
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLCf3afca82-ba8f-4741-8332-b7939aa0ee5e2026-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA203375
unii: 9D2RTI9KYH
unii: 6V9V2RYJ8N
unii: IXA7C9ZN03
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
unii: 9D2RTI9KYH