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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact 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