FDA.reportPublic FDA data

Healerz for Noses

Product NDC
50485-101
11-digit product format
504850101
Labeler code
50485
Product ID
50485-101_784ef895-d19f-4ab2-a26e-8eab661e4b02
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Wellco Brands LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-11-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50485-101IInactivated by FDA2026-07-31
excluded packagepackage50485-10150485-101-01IInactivated by FDA2026-07-31
excluded packagepackage50485-10150485-101-02IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50485-101-012020-01-31C16284748780-19d75b9cf-e465-f424-e053-dadaa90a57ceHealerz ™ ... for Noses
50485-101-022020-01-31C16284748780-19d75b9cf-e465-f424-e053-dadaa90a57ceHealerz ™ ... for Noses

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50485-101-01Healerz for Noses0.5 g in 1 PACKETCREAM0.52
50485-101-01Healerz for Noses6 in 1 BOXCREAM62
50485-101-02Healerz for Noses24 in 1 BOXCREAM242
50485-101-02Healerz for Noses0.5 g in 1 PACKETCREAM0.52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7HEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
LIDOCAINEACTIVE MOIETY98PI200987HEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FHEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50485-101HEALERZ FOR NOSES (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) CREAM [WELLCO BRANDS LLC]2Legacy NDC, 4 package rows20130516_96af69b6-42ed-4327-8fa5-a64dfc19d2ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN96af69b6-42ed-4327-8fa5-a64dfc19d2ec2
1356489Healerz for Noses (benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % ) Topical CreamPSN96af69b6-42ed-4327-8fa5-a64dfc19d2ec2
1356489benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream [Healerz for Noses]SBD96af69b6-42ed-4327-8fa5-a64dfc19d2ec2
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD96af69b6-42ed-4327-8fa5-a64dfc19d2ec2
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY96af69b6-42ed-4327-8fa5-a64dfc19d2ec2
1356489Healerz for Noses (benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % ) Topical CreamSY96af69b6-42ed-4327-8fa5-a64dfc19d2ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50485-101-01504850101010.5 g in 1 PACKET0.5 gHistorical
50485-101-025048501010224 in 1 BOXHistorical