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

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 Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990, 1313914

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13709-231-042020-04-18C16284748780-19d75b9d1-0369-f424-e053-dadaa90a57ceDrug Facts
13709-231-072020-04-18C16284748780-19d75b9d1-0369-f424-e053-dadaa90a57ceDrug Facts
13709-231-042020-01-31C16284748780-19d75b9d1-0369-f424-e053-dadaa90a57ceDrug Facts
13709-231-072020-01-31C16284748780-19d75b9d1-0369-f424-e053-dadaa90a57ceDrug 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#

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

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