FDA.reportPublic FDA data

NDC 51672-2030-05 - Oxymetazoline Hydrochloride 12-Hour

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
51672-2030
Requested NDC
51672-2030-05
Package NDCs from labels
51672-2030-5, 51672-2030-3, 51672-2030-05
Manufacturer
Sun Pharmaceutical Industries, Inc. | Applied Laboratories, Inc.
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxymetazoline Hydrochloride Nasal Decongestant 12-Hour SpraySun Pharmaceutical Industries, Inc. | Applied Laboratories, Inc.2026-07-16HUMAN OTC DRUG LABEL
OXYMETAZOLINE HYDROCHLORIDE - Rebel Distributors CorpRebel Distributors Corp2011-02-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2030-3Oxymetazoline Hydrochloride12-Hour30 mL in 1 BOTTLE, SPRAYSPRAY303
51672-2030-3Oxymetazoline Hydrochloride12-Hour1 in 1 CARTONSPRAY13
51672-2030-5Oxymetazoline Hydrochloride12-Hour15 mL in 1 BOTTLE, SPRAYSPRAY153
51672-2030-5Oxymetazoline Hydrochloride12-Hour1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2030OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20250316_34a79f8b-32b7-48db-a895-c942cc795292.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2030-3ML - Milliliter51672-20306438d50f-2bf2-4061-a793-5d3f37fb4b6112012-07-24
51672-2030-5ML - Milliliter51672-203050c5526b-5725-4806-b309-7c4fdb3242e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
polyethylene glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]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 2 of 255 · 5,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
unii: F5UM2KM3W7
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
rxcui: 1000990
unii: K89MJ0S5VY

Reported adverse events (FAERS/openFDA)#

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