FDA.reportPublic FDA data

Major Nasal Decongestant

Product NDC
0904-7435
11-digit product format
009047435
Labeler code
0904
Product ID
0904-7435_22987538-bbaf-4dce-ba33-325abacdec70
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
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
Major Nasal Decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edb49b17-06a7-4c25-bc7c-d62c1deac7f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7435-35Major Nasal Decongestant15 mL in 1 BOTTLE, SPRAYSPRAY152
0904-7435-35Major Nasal Decongestant1 in 1 CARTONSPRAY12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7435-35ML - Milliliter0904-7435955eff39-c5c2-4214-995a-2f1239c4859612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7435MAJOR NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20231231_edb49b17-06a7-4c25-bc7c-d62c1deac7f1.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 55 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Extra StrengthDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f33c1fb-150b-4083-a9a4-c0fbab4b61332026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution Inc5ca7dc60-af0c-47c6-b453-8b39c744eb5b2026-01-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inc2ce5f2af-cabc-466f-b0c5-256e6e6d4c882026-01-27WarningsExact identifier
application number: M012
Sinus Headache and Pain Day, Non-drowsyACETAMINOPHEN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEc33340c0-47d3-45e2-997b-3d9fb148900f2026-01-27WarningsExact identifier
application number: M012
Cold and Flu Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.b7501b59-d25a-49ec-9cbf-47018bce83972026-01-27WarningsExact identifier
application number: M012
good sense nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companyf90bd64a-dd1a-4319-87cd-427d57f677ab2026-01-26WarningsExact identifier
application number: M012
Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu PlusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc547ff880-3d40-4a4a-84ee-cd0d5290a9b92026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Day and Night Cold and FluMAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWAL-MART STORES INCd6a35fb8-1899-4da2-ad2b-0423e332845d2026-01-26WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINProdose, Inc.7e5de5b0-18f0-4807-8686-da9821f918ce2026-01-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb9fbf917-12b7-770f-e053-2995a90afe932026-01-26WarningsExact identifier
application number: M012
Maximum Strength Non Drowsy Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb58b2c36-a403-4dae-b3b2-f0ffd28a963b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc870e6bcb-84ab-45e0-ae57-08a9a182eb0b2026-01-26WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inceb8e83a4-981b-48a5-88f4-3a0ba358d3bc2026-01-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc8d2d765f-a7e3-40e6-b35d-0e8806a7ea592026-01-26WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU CHERRYPHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEWalgreen Company02a6781c-aa6f-8fb0-e063-6294a90a043d2026-01-26WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEWalgreen Company02e5f475-4e9f-2856-e063-6294a90a21fd2026-01-26WarningsExact identifier
application number: M012
GNP Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)AmerisourceBergen0bcc55bf-9654-120b-e063-6394a90a59d12026-01-26WarningsExact identifier
application number: M012
S2RACEPINEPHRINE HYDROCHLORIDENephron Pharmaceuticals Corporationdd1b35c7-b23b-4b95-8162-df3d263fe32e2026-01-26WarningsExact identifier
application number: M012
SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d97c634-0975-42d5-8ade-2ed2018cfe9d2026-01-26WarningsExact identifier
application number: M012
GOOD SENSE NIGHT TIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEL. Perrigo Companycd68289b-3850-40c6-9439-aae0e2d7637d2026-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNedb49b17-06a7-4c25-bc7c-d62c1deac7f12
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDedb49b17-06a7-4c25-bc7c-d62c1deac7f12
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYedb49b17-06a7-4c25-bc7c-d62c1deac7f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0904-7435-35009047435351 BOTTLE, SPRAY in 1 CARTON (0904-7435-35) / 15 mL in 1 BOTTLE, SPRAY2023-12-31NoNoCurrent