FDA.reportPublic FDA data

SinuFrin Plus

Product NDC
13709-232
11-digit product format
137090232
Labeler code
13709
Product ID
13709-232_0eb0fd3c-87e2-405d-e063-6294a90ae06f
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

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 Plus
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
99afe6a6-1350-49c6-9347-b7e531e35925Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-232-05SinuFrin PlusNeilMed15 mL in 1 BOXSPRAY159
13709-232-06SinuFrin PlusNeilMed15 mL in 1 BOTTLESPRAY159
13709-232-12SinuFrin PlusNeilMed1 in 1 CARTONSPRAY19
13709-232-12SinuFrin PlusNeilMed30 mL in 1 BOTTLESPRAY309

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
ALLANTOININACTIVE INGREDIENT344S277G0ZSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
ALOEINACTIVE INGREDIENTV5VD430YW9SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-232SINUFRIN PLUS NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20240112_99afe6a6-1350-49c6-9347-b7e531e35925.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 78 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb84f37bc-be37-4f2b-83ee-d7d1341844902025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b7c7fc-1068-f486-e053-2a95a90a8e8c2025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b9e0da-2c54-8b31-e053-2995a90a690b2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf6b3ca40-7638-477f-b800-4c28c40ff0a82025-12-11WarningsExact identifier
application number: M012
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC516ab016-31f9-4829-8b94-2f968933093c2025-12-11WarningsExact identifier
application number: M012
Sinus PE CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company5b9151b7-3e40-4f37-b3e0-4c0fa0115b712025-12-10WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDiscount Drug Mart2344c048-0550-4c31-b54e-a198910c490e2025-12-10WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACY, INCcf4eb4c4-68e0-4478-a81c-d3d1e66f5cc52025-12-10WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe, Lil Drug StoreACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Incf395c196-62d7-47ff-b38d-af37adf5980b2025-12-10WarningsExact identifier
application number: M012
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Incd956f1b8-91f8-424b-bb6c-704c445b6f4c2025-12-10WarningsExact identifier
application number: M012
good neighbor pharmacy day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergene5c1bd96-d27d-49c1-b3b8-eee53a145ef52025-12-10WarningsExact identifier
application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe0f43-b92a-f947-e063-6394a90ab72c2025-12-10WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7285fe0-5a5b-42c4-be47-9a07a2ba75e82025-12-10WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporationf9b8dbe1-7ff9-4320-850c-6e86e98d43932025-12-09WarningsExact identifier
application number: M012
Severe NasalOXYMETAZOLINE HYDROCHLORIDE 0.05%ALAINA HEALTHCARE PRIVATE LIMITED27747a10-8d1d-41c2-80b9-45452f3b9abc2025-12-09WarningsExact identifier
application number: M012
Vaporizing RubCAMPHOR, EUCALYPTUS OIL AND MENTHOLALAINA HEALTHCARE PRIVATE LIMITED4c6a7ac0-be76-42b0-9a08-b287e70a34602025-12-09WarningsExact identifier
application number: M012
24-7 Life BY 7-ELEVEN Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store products, Inc.277363f4-1c00-ddb7-e063-6294a90a46772025-12-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN99afe6a6-1350-49c6-9347-b7e531e359259
1313914Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal SprayPSN99afe6a6-1350-49c6-9347-b7e531e359259
1313914oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]SBD99afe6a6-1350-49c6-9347-b7e531e359259
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD99afe6a6-1350-49c6-9347-b7e531e359259
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY99afe6a6-1350-49c6-9347-b7e531e359259
1313914Sinufrin Plus 0.05 % Nasal SpraySY99afe6a6-1350-49c6-9347-b7e531e359259
1313914Sinufrin Plus 0.5 MG/ML Nasal SpraySY99afe6a6-1350-49c6-9347-b7e531e359259

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13709-232-051370902320515 mL in 1 BOX (13709-232-05) 15 ml2012-07-150000-00-00NoNoCurrent
13709-232-061370902320615 mL in 1 BOTTLE (13709-232-06) 15 ml2012-07-150000-00-00NoNoCurrent
13709-232-12137090232121 BOTTLE in 1 CARTON (13709-232-12) / 30 mL in 1 BOTTLE1 bottle2021-04-210000-00-00NoNoCurrent