FDA.reportPublic FDA data

DERMFREE ORIGINAL NASAL

Product NDC
85248-112
11-digit product format
852480112
Labeler code
85248
Product ID
85248-112_572bb880-5d41-7d4b-e063-6394a90ac312
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline HCL 0.05%ORIGINAL NASAL
Dosage form
SPRAY
Route
NASAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
Substance
NAPHAZOLINE HCL
Active strength
.05 g/100mL
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
DERMFREE ORIGINAL NASAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HCL.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZ1131787DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046610Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a4d3a2b-a4ed-c736-e063-6394a90a96dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-112-01DERMFREE ORIGINAL NASAL30 mL in 1 BOTTLESPRAY301

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 56 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Seacall Nasal Spray.NASAL SPRAYGuangdong Quadrant Ecological Technology Co., Ltd.1f12618b-7461-fb47-e063-6294a90af7532026-01-23WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf7d210-102c-4053-81f6-67116de6cf7b2026-01-23WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergen44f9255b-0bf9-4573-ac9c-410acb515bc22026-01-23WarningsExact identifier
application number: M012
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
application number: M012
good neighbor pharmacy night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergene2b5c27e-ca5f-4503-a3ce-c86e1d8070a72026-01-23WarningsExact identifier
application number: M012
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR GUAIFENESINStrategic Sourcing Services LLC84750bfb-9e94-40a3-b731-21799f5e4fd12026-01-20WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services Inc0a651316-623e-41eb-ab3a-641f5d8074252026-01-20WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and FluWALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWalgreens579c47c8-6366-4785-9680-d3986ce9641d2026-01-19WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and ColdWALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLDWalgreensdd61c9d3-0b70-450e-9525-282710b383cc2026-01-19WarningsExact identifier
application number: M012
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensfc670515-a820-4ea7-8786-8ae710798b312026-01-19WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREENS9dece7b1-00b1-2499-e053-2a95a90a0be32026-01-19WarningsExact identifier
application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreens2dba2bec-e0e3-4910-89c5-ebc093e05bec2026-01-19WarningsExact identifier
application number: M012
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVEREACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreensca3c1eb4-6099-5e5f-e053-2995a90ab61b2026-01-19WarningsExact identifier
application number: M012
SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENSfe6dff90-18f1-491e-84b9-cc74bb1831ba2026-01-19WarningsExact identifier
application number: M012
Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens Companyec8c73d5-b190-432a-92c6-68ea0fc86ea62026-01-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046610naphazoline HCl 0.05 % Nasal SprayPSN4a4d3a2b-a4ed-c736-e063-6394a90a96df1
1046610naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4a4d3a2b-a4ed-c736-e063-6394a90a96df1
1046610naphazoline HCl 0.05 % Nasal SpraySY4a4d3a2b-a4ed-c736-e063-6394a90a96df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-112-018524801120130 mL in 1 BOTTLE (85248-112-01) 30 ml2026-02-08NoNoCurrent