FDA.reportPublic FDA data

Nasal Solution

Product NDC
84008-101
11-digit product format
840080101
Labeler code
84008
Product ID
84008-101_4872ea4e-61d1-73c8-e063-6394a90a240f
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal Solution
Dosage form
LIQUID
Route
NASAL
Labeler
Bullet Point LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-20
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675369Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e105e77-770b-d198-e063-6394a90a124fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84008-101-01Nasal Solution30 mL in 1 BOTTLELIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84008-101NASAL SOLUTION LIQUID [BULLET POINT LLC]2Current NDC, 1 package rows20240720_0e105e77-770b-d198-e063-6394a90a124f.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nasal SolutionNASAL SOLUTIONBullet Point LLC0e105e77-770b-d198-e063-6394a90a124f2026-01-01WarningsExact identifier
ndc (product): 84008-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675369povidone-iodine 1 % Nasal SprayPSN0e105e77-770b-d198-e063-6394a90a124f3
2675369povidone-iodine 10 MG/ML Nasal SpraySCD0e105e77-770b-d198-e063-6394a90a124f3
2675369povidone-iodine 1 % Nasal SpraySY0e105e77-770b-d198-e063-6394a90a124f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84008-101-018400801010130 mL in 1 BOTTLE (84008-101-01) 30 ml2024-02-20NoNoCurrent