FDA.reportPublic FDA data

SinuFrin

Product NDC
13709-231
11-digit product format
137090231
Labeler code
13709
Product ID
13709-231_0eb0d276-2eba-1c8d-e063-6294a90ae9ff
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
NeilMed Pharmaceuticals Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-15
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
7.5 mg/15mL
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct13709-231EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage13709-23113709-231-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage13709-23113709-231-07EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
SinuFrin
Brand name suffix
NeilMed
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE7.5 mg/15mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1313914Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9ec6ac3-1e00-4e97-97c8-b2cd66a752aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
13709-231-042020-04-18Drug Facts
13709-231-072020-04-18Drug Facts
13709-231-042020-01-31Drug Facts
13709-231-072020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-231-04SinuFrinNeilMed15 mL in 1 BOXSPRAY157
13709-231-07SinuFrinNeilMed15 mL in 1 BOTTLESPRAY157
13709-231-12SinuFrinNeilMed30 mL in 1 BOTTLESPRAY307
13709-231-12SinuFrinNeilMed1 in 1 CARTONSPRAY17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3
WATERINACTIVE INGREDIENT059QF0KO0RSINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-231SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 4 package rows20240112_f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae.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 177 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2023-01-17WarningsExact identifier
application number: M012
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992023-01-17WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH-E-Bdb19b8c7-0334-0664-e053-2a95a90ad61f2023-01-14WarningsExact identifier
application number: M012
NightimeACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEH-E-Bdb44560b-da02-74c9-e053-2a95a90af0b62023-01-13WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCLWalgreensdbf5656b-9105-871b-e053-2995a90a49412023-01-03WarningsExact identifier
application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa2508699-08c0-4a22-e053-2a95a90a8a6d2022-11-02WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINPAI Holdings, LLC dba PAI Pharmac2e53fb5-2798-47c8-9285-d1077d46e6292022-06-14WarningsExact identifier
application number: M012
Mucus Relief DMMUCUS RELIEF DMTopCo Associates, LLC71674a9b-89ed-43d1-aadb-b9311fdfbdf92022-06-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Combo PackDAYTIME NIGHTTIME COLD AND FLUAllegiant Healthfa7ed5db-4da7-46b4-a08d-1d79cb7a56742022-05-19WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMGood Sense26a199bf-57e5-4f36-b40c-83a1187e48702022-05-18WarningsExact identifier
application number: M012
Mucus Relief DM Immediate ReleaseMUCUS RELIEF DMAllegiant Health731f8608-ad5b-491e-a4d4-2bb0c423fed52022-05-18WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb3c229a4-c772-70fb-e053-2a95a90a72db2022-03-11WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEGood Sensef88e2654-8e97-4cf6-9c36-01aeb51a91022021-11-30WarningsExact identifier
application number: M012
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
application number: M012
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGGood Sensee7c68746-7ec0-46cf-b4a3-174fab819b5e2021-05-05WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESIN 400MGTopCo Associates, LLC7d91c6ab-d161-42b9-b353-0aa8f59619f82021-01-21WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
application number: M012
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1313914Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal SprayPSNf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1313914oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]SBDf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1313914Sinufrin Plus 0.05 % Nasal SpraySYf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7
1313914Sinufrin Plus 0.5 MG/ML Nasal SpraySYf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13709-231-041370902310415 mL in 1 BOX (13709-231-04) 15 ml2012-07-150000-00-00NoNoCurrent
13709-231-071370902310715 mL in 1 BOTTLE (13709-231-07) 15 ml2012-07-150000-00-00NoNoCurrent
13709-231-12137090231121 BOTTLE in 1 CARTON (13709-231-12) / 30 mL in 1 BOTTLE1 bottle2021-04-210000-00-00NoNoCurrent