FDA.reportPublic FDA data

equaline nasal

Product NDC
41163-703
11-digit product format
411630703
Labeler code
41163
Product ID
41163-703_00703ca9-7bc4-48a8-9e49-3688fffce57f
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-03
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
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
equaline nasal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69308693-a094-42a9-a041-e73647a25cc1Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-703-10equaline nasal30 mL in 1 BOTTLE, PUMPSPRAY, METERED308
41163-703-10equaline nasal1 in 1 CARTONSPRAY, METERED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-703EQUALINE NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 2 package rows20240906_69308693-a094-42a9-a041-e73647a25cc1.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 113 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLC40a6a7e3-6ec9-4005-9406-9d5b044b3c212025-06-16WarningsExact identifier
application number: M012
Daytime Nighttime Sinus ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation23f50b88-52c3-2029-e063-6394a90ac73e2025-06-14WarningsExact identifier
application number: M012
Cough Drops Dollar General Berries Flavor 25ctPECTINDollar General Corporationc53c19a9-5984-4b08-ae46-a53dc8bb7d742025-06-13WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry Flavor 25ctPECTINDollar General Corporationd82034ca-b7fd-48c8-ab4a-8e1e564183242025-06-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBelleview Biosciences1db57d86-39f0-f8ca-e063-6394a90a63972025-06-12WarningsExact identifier
application number: M012
TARGET Cold and Cough and Nighttime Value PackBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,TARGET CORPORATIONce536313-7265-405c-88b7-f45e62781da52025-06-11WarningsExact identifier
application number: M012
Capron MaxDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLC3756812b-f128-8946-e063-6294a90a59ba2025-06-11WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES60311ca3-8544-417e-aa29-e9f65c6692ba2025-06-11WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65d2815-6932-123c-e053-2a95a90a2cf92025-06-10WarningsExact identifier
application number: M012
Cold Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company0cc66c6c-db26-4bb2-a97d-c4106210d70c2025-06-10WarningsExact identifier
application number: M012
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTCf4ff84b3-bb0c-4900-8ba4-6d1b903947822025-06-09WarningsExact identifier
application number: M012
Equate Kids Daytime Dex Cough GelsDEXTROMETHORPHANWalmart37269cd6-1528-9879-e063-6394a90a2b542025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLCf5764925-c586-40e4-8252-24d92389af012025-06-09WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLC7fa8e4ad-95cb-4905-90db-d53b3bc87c412025-06-09WarningsExact identifier
application number: M012
Vaporizing Steam LiquidMEDICATED COUGH SUPPRESSANTNeilMed Pharmaceuticals Inc.36cf6218-adb8-9d8b-e063-6394a90a49a02025-06-05WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN69308693-a094-42a9-a041-e73647a25cc18
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD69308693-a094-42a9-a041-e73647a25cc18
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY69308693-a094-42a9-a041-e73647a25cc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-703-10411630703101 BOTTLE, PUMP in 1 CARTON (41163-703-10) / 30 mL in 1 BOTTLE, PUMP2018-04-030000-00-00NoNoCurrent