FDA.reportPublic FDA data

DERMFREE ORIGINAL NASAL

Product NDC
85248-111
11-digit product format
852480111
Labeler code
85248
Product ID
85248-111_572bb135-2229-79fb-e063-6394a90a9c93
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline HCL0.05%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
4a4d0c03-7d8f-76cb-e063-6394a90a938cAvailable 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
85248-111-01DERMFREE 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 114 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLCbad89968-22a7-4287-a57c-9e6206e574fe2025-06-16WarningsExact identifier
application number: M012
Herbal Throat DropsLEMON MINT HERBALMeijer, Inc.37dd58ad-95d1-568c-e063-6394a90a94332025-06-16WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046610naphazoline HCl 0.05 % Nasal SprayPSN4a4d0c03-7d8f-76cb-e063-6394a90a938c1
1046610naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD4a4d0c03-7d8f-76cb-e063-6394a90a938c1
1046610naphazoline HCl 0.05 % Nasal SpraySY4a4d0c03-7d8f-76cb-e063-6394a90a938c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-111-018524801110130 mL in 1 BOTTLE (85248-111-01) 30 ml2026-02-08NoNoCurrent