Saline

Product NDC
67777-310
11-digit product format
677770310
Labeler code
67777
Product ID
67777-310_59e1efc0-3b88-a73c-e063-6394a90acd02
Type
HUMAN OTC DRUG
Nonproprietary name
Saline Nasal Spray
Dosage form
SPRAY
Route
NASAL
Labeler
Dynarex Corporation
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-24
Substance
SODIUM CHLORIDE
Active strength
.65 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
Saline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE.65 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
707251Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3247ae7d-554f-baab-e063-6294a90aa3ecAvailable on FDA.report

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 28 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureLife Topical AnestheticBENZOCAINEPureLife Dental9f2bdc10-6b41-4606-a65c-560d204fdb972025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalea8e5036-8c30-4527-9f0b-5c474bb0debd2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalf9b9b085-ff61-4771-8d41-758bd061d9082025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental8c2cec48-d19c-45b5-9f9a-c35358f369272025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.e629fbd0-7dc7-4c26-b221-6c5db80faa3c2025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.170ce528-7115-463c-b360-1d7a958bbd812025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.2a93e8fb-bb0d-4b0f-b5e7-ff1fe4ebb7982025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c85e741b-da75-44ce-805e-5dde39795bd92025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9fb0c45e-19b1-4b3b-adb7-e467bde03aa42025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalc75195b6-f8b4-4fda-a162-5dd95bd9ab312025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalb6e25b54-4734-4769-9d1e-2d1187fdae192025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental1142e94e-0de1-4e8a-8eaf-a8dc0d08a2902025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9a9d71ff-121c-f6af-e053-2995a90ad27f2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4429a22e-2e3e-4519-b0a3-c1d86a62aba22025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89b7e919-2656-4b1b-ab5c-5b11d42b52f32025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05cf428c-3bc8-5fcb-e063-6394a90a962a2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental3cc5d095-5f9c-4e4d-8971-0079e949b7ca2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89d23b14-398e-4b3e-955a-724ff66579b92025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentale381b2d5-6485-4d11-94f4-eec335d5cf412025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental8ffc4af6-d99c-4964-8d7d-4644bc699a3d2025-01-08WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-310-026777703100272 BOTTLE in 1 CASE (67777-310-02) / 44 mL in 1 BOTTLE (67777-310-01) 72 bottle2025-04-24NoNoCurrent
67777-310-046777703100472 BOTTLE in 1 CASE (67777-310-04) / 89 mL in 1 BOTTLE (67777-310-03) 72 bottle2025-04-24NoNoCurrent