FDA.reportPublic FDA data

NDC 0904-0053-20 - Rabofen DM

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
0904-0053
Requested NDC
0904-0053-20
Package NDCs from labels
0904-0053-00, 0904-0053-09, 0904-0053-16, 0904-0053-20
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rabofen™ DMNuCare Pharmaceuticals,Inc.2021-05-12HUMAN OTC DRUG LABEL
Rabofen DM - A-S Medication SolutionsA-S Medication Solutions2020-01-18HUMAN OTC DRUG LABEL
Rabofen DM - Major PharmaceuticalsMajor Pharmaceuticals2019-09-25HUMAN OTC DRUG LABEL
Rabofen™ DMPreferred Pharmaceuticals Inc.2019-03-20HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0053-00ML - Milliliter0904-00537d3648b9-4173-4706-b15e-f3bc2efa8c5112017-11-06
0904-0053-09ML - Milliliter0904-0053c62f2a5e-307c-4dd3-8b1a-8a0b9ba660a812017-11-06
0904-0053-16ML - Milliliter0904-00536683dffc-731f-494b-acdd-ce0d72142d6012017-11-06
0904-0053-20ML - Milliliter0904-005375c95baa-38ce-4e45-8303-e6b31bbe9a7f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
DextromethorphanACTIVE MOIETY7355X3ROTSTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MAJOR PHARMACEUTICALS]1

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 253 · 5,048 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 495W7451VQ
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 9D2RTI9KYH
12 hr relief cough dmDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED03c44e2f-d6e3-4c78-9c9a-92d1708a62fe2026-09-16WarningsExact identifier
unii: 9D2RTI9KYH
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: L7T10EIP3A
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: 9D2RTI9KYH
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.