Sterile Hypertonic Saline Solution 7 Sodium Chloride

Product NDC
80327-009
11-digit product format
803270009
Labeler code
80327
Product ID
80327-009_29f1c913-855a-ff60-e063-6294a90ad936
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
JOONEM LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-04-01
Substance
SODIUM CHLORIDE
Active strength
70 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Hypertonic Saline Solution 7 Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE70 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80327-009-012024-01-30C16284748780-11030e365-6112-111a-e063-dadaa90a10e2Sterile Hypertonic Saline Solution 7% Sodium Chloride USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80327-009-01Sterile Hypertonic Saline Solution 7 Sodium Chloride5 mL in 1 VIALLIQUID55
80327-009-01Sterile Hypertonic Saline Solution 7 Sodium Chloride1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80327-009STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE (SODIUM CHLORIDE) LIQUID [JOONEM LLC]5Current NDC, Legacy NDC, 2 package rows20241225_e7110525-9f9b-5b68-e053-2995a90ac034.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80327-009-01803270009011 VIAL in 1 CARTON (80327-009-01) / 5 mL in 1 VIAL1 vial2022-04-010000-00-00NoNoCurrent