FDA.reportPublic FDA data

PROPOLIS NASAL PLUS

Product NDC
82123-021
11-digit product format
821230021
Labeler code
82123
Product ID
82123-021_495e0d14-b3c3-42c0-e063-6394a90a89fe
Type
HUMAN OTC DRUG
Nonproprietary name
PLUS NASAL
Dosage form
LIQUID
Route
NASAL
Labeler
SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-03
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
15.21 mg/30mL
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
PROPOLIS NASAL PLUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE15.21 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup
O414PZ4LPZInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5d52f13-a649-9579-e053-2a95a90a062cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82123-021-30PROPOLIS NASAL PLUS30 mL in 1 BOTTLE, GLASSLIQUID309
82123-021-31PROPOLIS NASAL PLUS1 in 1 BOXLIQUID19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82123-021PROPOLIS NASAL PLUS (PLUS NASAL) LIQUID PROPOLIS NASAL (NASAL) LIQUID SUNSCREEN SPF50 (NON NANO ZINC OXIDE) CREAM SUNSCREEN FOR FACE SPF50 (NON NANO ZINC OXIDE) CREAM AFTERSUN (NON NANO ZINC OXIDE) CREAM DIAPER RASH CREAM (NON NANO ZINC OXIDE) CREAM SUNSCREEN FOR KIDS SPF50 (NON NANO ZINC OXIDE) CREAM S.O.S CREAM INTENSIVE MOISTURIZING SKIN PROTECTANT (NON NANO ZINC OXIDE) CREAM ACNE CONTROL SERUM (SALICYLIC ACID) LIQUID [SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI]8Current NDC, 2 package rows20240907_c5d52f13-a649-9579-e053-2a95a90a062c.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 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
application number: M012
TusnelDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division805dc611-355a-4af5-bf19-464c3290c5c62025-12-31WarningsExact identifier
application number: M012
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONcc774d33-96ce-4992-ad30-3cb03b0d119d2025-12-31WarningsExact identifier
application number: M012
Tusnel SFDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cb43b4df-5ccc-416e-abcd-98f079b3f2bb2025-12-31WarningsExact identifier
application number: M012
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.63541753-de8d-42fe-a9b3-a5eac3fcdca42025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
application number: M012
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
application number: M012
Tusnel-DM PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION64e36b02-b5be-4d20-8818-cb5b235966712025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f89a64-f4a4-f909-e053-2a91aa0ad44d2025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f65f59-7ea1-adce-e053-2991aa0a6f1f2025-12-31WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLBestco Inc.77f9e176-d87a-beed-e053-2991aa0aac202025-12-31WarningsExact identifier
application number: M012
Sugar Free Cherry Cough DropsMENTHOLBestco Inc.7858f380-bef7-3d30-e053-2a91aa0a7ea62025-12-31WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLBestCo Inc.26a22cfd-395b-4ffb-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M012
Limpia PechoDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf32025-12-31WarningsExact identifier
application number: M012
Cherry Sore Throat LozengesBENZOCAINEBestco Inc.737efd41-2d59-6013-e053-2a91aa0a6c632025-12-31WarningsExact identifier
application number: M012
Best Health Menthol Cough DropsMENTHOLBestco LLCdda66a3c-9006-ff1a-e053-2a95a90abfb32025-12-31WarningsExact identifier
application number: M012
Rynex DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEdwards Pharmaceuticals, Inc7be2c282-24ba-4f19-9b14-872d3f5746a72025-12-31WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82123-021-308212300213030 mL in 1 BOTTLE, GLASS30 mlHistorical
82123-021-31821230021311 BOTTLE, GLASS in 1 BOX (82123-021-31) / 30 mL in 1 BOTTLE, GLASS (82123-021-30) 2023-10-03NoNoCurrent