FDA.reportPublic FDA data

Sinufrin Decongestant

Product NDC
13709-355
11-digit product format
137090355
Labeler code
13709
Product ID
13709-355_52a2e5f9-e0a3-02f7-e063-6294a90a3ae9
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal Congestion Relief
Dosage form
SOLUTION
Route
NASAL
Labeler
NeilMed Pharmaceuticals Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-25
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
2027-12-31
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 Decongestant
Listing expiration
2027-12-31

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
52a2e5f9-e0a2-02f7-e063-6294a90a3ae9Available 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
13709-355-01Sinufrin Decongestant1 in 1 CARTONSOLUTION11
13709-355-01Sinufrin Decongestant15 mL in 1 BOTTLESOLUTION151

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 50 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
application number: M012
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALMART STORES INC18436026-b0e4-4481-a647-d735a27d0b002026-02-19WarningsExact identifier
application number: M012
VaporizingCAMPHORMeijer, Inc.7afc98d7-f64f-42d5-9022-28ad6b01db8a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEKroger Company8196b482-070e-4d7d-8943-129141f926ee2026-02-19WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy Chews BubblegumDIPHENHYDRAMINE HCLWALMART STORES INC9f83d2f0-9718-4f2b-bc7f-e29ba29174122026-02-19WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
application number: M012
Allergy Relief Dye-FreeDIPHENHYDRAMINE HCLCVS Pharmacy08459cf4-feb3-4283-88e1-d61e030c57f92026-02-19WarningsExact identifier
application number: M012
allergy reliefCHLORPHENIRAMINE MALEATERite Aid Corporationb0d70488-ea1d-4c1d-bd07-53dfb0e4d03c2026-02-18WarningsExact identifier
application number: M012
Walgreens Wild Cherry Pectin Throat DropsPECTINWalgreens424fda2d-c1e5-0ed9-e063-6394a90a06ea2026-02-18WarningsExact identifier
application number: M012
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEAmerisource Bergeneeda80ff-212d-428e-a0c6-782f271357b42026-02-18WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact identifier
application number: M012
Cold and Flu Severe, Day, NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.6e6bae79-1231-4b74-81c1-f0c914ed4af32026-02-17WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862026-02-17WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3fb49f64-2d77-44db-8186-5904837eedbe2026-02-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1313914Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal SprayPSN52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1313914oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]SBD52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1313914Sinufrin Plus 0.05 % Nasal SpraySY52a2e5f9-e0a2-02f7-e063-6294a90a3ae91
1313914Sinufrin Plus 0.5 MG/ML Nasal SpraySY52a2e5f9-e0a2-02f7-e063-6294a90a3ae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-355-01137090355011 BOTTLE in 1 CARTON (13709-355-01) / 15 mL in 1 BOTTLE1 bottle2026-05-25NoNoCurrent