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
O414PZ4LPZInternal UNII lookup
K89MJ0S5VYInternal 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 157 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.445e49a2-6ed0-434c-aaea-3ce14bc7df592024-08-12WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.d49b42ad-0ae0-48c9-adba-5fc2ced977642024-08-12WarningsExact identifier
application number: M012
RYMEDDEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.c1d6e914-74cc-4cdf-9587-7eaaa4a386e52024-08-12WarningsExact identifier
application number: M012
WesTussin DM NFWESTUSSIN DM NFWestminster Pharmaceuticals, LLC4e0f9f97-a31c-41ac-9d6c-d81efd20fcef2024-08-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.2f2a2864-af11-4240-bdad-a54aca58d01b2024-08-07WarningsExact identifier
application number: M012
Cold plus Flu Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0199aea2-a9c1-4c9d-8786-28b9dadc832e2024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.32d1ce6e-2617-4b50-a9e6-2e1941465dff2024-08-07WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.07362db5-a372-4463-af8b-06e8783ca8652024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.1fb11d90-48bf-4baa-9b3a-5d64d81e3a062024-08-07WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.574774b2-9813-4799-9cd4-27e296dd85842024-08-07WarningsExact identifier
application number: M012
Cold Max Day and NIghtACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.a92bcefb-ba29-4b3f-a60b-b4476ca8cf042024-08-07WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.778f1f5a-fd04-456f-90d0-998b93e774a52024-08-07WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.990f3232-bc75-45cf-8a50-cd7861d83f982024-08-07WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.0f5f25c6-7389-4285-b8d5-463cb7b6fcc42024-08-07WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATECare One (Retail Business Services, LLC.)a9a5b39d-b4c8-414e-8fe7-4c0601f751972024-08-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packagingb94feeb6-f33f-410d-a9b0-776b1ccf34a92024-08-04WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact 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