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 31 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8282a4a6-b77c-75fc-e053-2991aa0ad4ac2024-12-16WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.9452bff4-8c08-eff9-e053-2a95a90a67ed2024-12-16WarningsExact identifier
application number: M022
PHENOLPHENOLCHAIN DRUG MARKETING ASSOCIATION INC.2379e23a-72fe-4e94-9d7e-9b623c0db1742024-12-13WarningsExact identifier
application number: M022
KANKA SoftBrushBENZOCAINE AND ZINC CHLORIDEBlistex Inc093f3545-1d8e-48a3-a533-e9c3ae6d740b2024-12-12WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.826eaef8-4457-3dc2-e053-2991aa0a528b2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.8281700c-10f9-841c-e053-2991aa0a918f2024-12-11WarningsExact identifier
application number: M022
TopicaleBENZOCAINEMedical Products Laboratories, Inc.82824416-80de-76bd-e053-2a91aa0ad8b52024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories,Inc.e3da0e63-a891-72bd-e053-2a95a90a58bc2024-12-11WarningsExact identifier
application number: M022
Topicale XtraBENZOCAINEMedical Products Laboratories, Inc.e3d924b5-0788-46d3-e053-2995a90a027b2024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.fa433031-7376-0e5b-e053-6394a90a5f752024-12-11WarningsExact identifier
application number: M022
Fluoride BitsSODIUM MONOFLUOROPHOSPHATE 0.76%The Kind Lab, Inc.eedf13dc-a009-027a-e053-2995a90a8ec82024-12-11WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.763e8234-60be-4b1f-9f78-01c574f35d0a2024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.989f8509-cd28-48e7-9aa1-baddfbcac95a2024-12-10WarningsExact identifier
application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola USA Inc.f75c8967-40e6-473a-b403-941354cb0be12024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.c56be34d-1dd5-4200-9723-3a73180cb7592024-12-10WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola USA Inc.89257ceb-af0f-4516-88f7-6dfdab9e14f42024-12-10WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola USA Inc.9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b952024-12-10WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.6a81e5c7-834d-44da-853f-8f61032363112024-12-10WarningsExact identifier
application number: M022
SUGAR FREE SWISS CHERRY HERB THROAT DROPSMENTHOLRicola USA Inc.8a24f614-8e21-4ab2-8c0e-6af947911ccd2024-12-10WarningsExact identifier
application number: M022
RICOLA MAX NASAL CARE COOL MENTHOLMENTHOLRicola USA Inc.a2e189a2-65ae-48a9-99ad-8795334082df2024-12-10WarningsExact 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