FDA.reportPublic FDA data

oxymetazoline hydrochloride

Product NDC
68071-3422
11-digit product format
680713422
Labeler code
68071
Product ID
68071-3422_36b1caf3-8f0e-088c-e063-6394a90a6a07
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-05
Marketing end
2027-02-28
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-3422-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-3422-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-3422-10efc9e666f02…f202fb6c5f17…

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
oxymetazoline hydrochloride

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
fd058e2b-5445-e416-e053-6394a90a611bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3422-12025-03-04C16284748780-12cef2736-8f70-d83d-e063-dadaa90ab31fPerrigo Oxymetazoline HCl 0.05% Drug Facts
68071-3422-12025-01-30C16284748780-12cef2736-8f70-d83d-e063-dadaa90ab31fPerrigo Oxymetazoline HCl 0.05% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3422-1oxymetazoline hydrochloride30 mL in 1 BOTTLE, SPRAYSPRAY303
68071-3422-1oxymetazoline hydrochloride1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3422OXYMETAZOLINE HYDROCHLORIDE SPRAY [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250306_fd058e2b-5445-e416-e053-6394a90a611b.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 77 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLSALADO SALES INC.8f66f5bc-7c77-420b-9feb-911c980fbfdc2025-12-12WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.de55a9fd-53a2-4f3e-82b7-cabcbe287d462025-12-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESALADO SALES INC.cc73b668-cc6a-41d6-800a-4988c59c04492025-12-12WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC75269bcc-3bb2-49a0-8788-6b7da18796d32025-12-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus plus AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEaffac07f-d645-4999-98ee-7467902f5adc2025-12-12WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp8fd0071b-c6ca-49e6-b159-45dead71b6642025-12-11WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp098582dc-3e12-782f-e063-6394a90aa1a12025-12-11WarningsExact identifier
application number: M012
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY2e751d67-51b4-4b74-a9e8-7f3bc56369842025-12-11WarningsExact identifier
application number: M012
Pressure and Pain Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY232acb86-7383-4992-b333-1e47bf7c06ad2025-12-11WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY72847721-9f59-4af1-8f20-dc84497429182025-12-11WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401317-0295-14b3-e053-2a95a90acbb42025-12-11WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1ba37b8-4558-0808-e053-2995a90a9f5e2025-12-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNfd058e2b-5445-e416-e053-6394a90a611b3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDfd058e2b-5445-e416-e053-6394a90a611b3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYfd058e2b-5445-e416-e053-6394a90a611b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3422-1680713422011 BOTTLE, SPRAY in 1 CARTON (68071-3422-1) / 30 mL in 1 BOTTLE, SPRAY2023-05-312027-02-28NoNoHistorical