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 168 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIGRIP NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLPharmadel LLC12de30fd-95b6-f16d-e063-6294a90aeba22024-03-27WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)0044c53c-11dd-41a9-a5d9-622dd8b1c1442024-03-27WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINBryant Ranch Prepack9812056b-736e-40c5-ae60-21dd9221397c2024-03-22WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)1b7b5811-722e-4c4a-844d-c05fa5cfb2e52024-03-21WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2a77c3-7d0f-157b-e053-2995a90a951a2024-03-19WarningsExact identifier
application number: M012
Robitussin Medi-SoothersDEXTROMETHORPHAN HYDROBROMIDE, MENTHOLHaleon US Holdings LLC6bec225e-a203-4866-b0db-b76f73a6ae252024-03-19WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)06d47104-a8ca-48cc-b27e-08c9d018c37b2024-03-19WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)b80dae7f-ed2d-4a9e-bef9-f1ed8add01742024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWALGREENSc945c35e-de0d-0fd6-e053-2995a90a1fbf2024-03-19WarningsExact identifier
application number: M012
Daytime Nighttime Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCLWalgreensda046b01-707c-326a-e053-2995a90a09272024-03-19WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensda2b0276-9ab0-38e6-e053-2a95a90a54d82024-03-19WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCb9772292-9eb6-47cf-abb8-007c254780902024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Cough Long-ActingDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC75bc7827-4439-e6a8-a65c-7154d5592e582024-03-17WarningsExact identifier
application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
application number: M012
ANTIGRIP DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLC12f20aba-f991-bd82-e063-6294a90a4aac2024-03-16WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWALGREENSd3053f80-aece-eb50-e053-2a95a90a59452024-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCLWALGREENSd315bc95-1b46-75df-e053-2a95a90a6c662024-03-15WarningsExact identifier
application number: M012
MAR-COF CG ExpectorantCODEINE PHOSPHATE AND GUAIFENESINMarnel Pharmaceuticals, LLC60a41229-b125-43d8-b2b4-0bf40feed7642024-03-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INC97aa0b90-1230-4143-b5d3-18b96a6b7b4f2024-03-15WarningsExact identifier
application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC036162c9-f5a6-418e-bd5e-ebd72097d27d2024-03-15WarningsExact 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