FDA.reportPublic FDA data

Zicam Intense Sinus Relief

Product NDC
10237-471
11-digit product format
102370471
Labeler code
10237
Product ID
10237-471_5a5c280f-6d7f-8a68-e063-6294a90a1a54
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Church & Dwight Co., Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-28
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
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
Zicam Intense Sinus Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

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
1001084Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d916f7ff-84b7-57ef-e053-2995a90a3efaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-471-15Zicam Intense Sinus Relief15 mL in 1 BOTTLE, PLASTICSPRAY153
10237-471-15Zicam Intense Sinus Relief1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-471ZICAM INTENSE SINUS RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 2 package rows20241121_d916f7ff-84b7-57ef-e053-2995a90a3efa.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 118 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
application number: M012
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp31aa54d8-df8d-f1ae-e063-6294a90a96222025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBryant Ranch Prepack59aeb692-2f79-45aa-8e6a-dab77cd3b2f92025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEOncor Pharmaceuticals06ecba97-c790-4672-a8c3-f9caf6272d262025-03-27WarningsExact identifier
application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNd916f7ff-84b7-57ef-e053-2995a90a3efa3
1001084Zicam Congestion Relief 0.05 % Nasal SprayPSNd916f7ff-84b7-57ef-e053-2995a90a3efa3
1001084oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Zicam Sinus Relief]SBDd916f7ff-84b7-57ef-e053-2995a90a3efa3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDd916f7ff-84b7-57ef-e053-2995a90a3efa3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYd916f7ff-84b7-57ef-e053-2995a90a3efa3
1001084Zicam Extreme Congestion Relief 0.05 % Nasal SpraySYd916f7ff-84b7-57ef-e053-2995a90a3efa3
1001084Zicam Sinus Relief 0.05 % Nasal SpraySYd916f7ff-84b7-57ef-e053-2995a90a3efa3
1001084Zicam Sinus Relief 0.5 MG/ML Nasal SpraySYd916f7ff-84b7-57ef-e053-2995a90a3efa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10237-471-15102370471151 BOTTLE, PLASTIC in 1 CARTON (10237-471-15) / 15 mL in 1 BOTTLE, PLASTIC2022-02-280000-00-00NoNoCurrent