ammonia inhalants

Product NDC
85813-003
11-digit product format
858130003
Labeler code
85813
Product ID
85813-003_56efb675-1f3d-4364-89d6-ef4f80e20d50
Type
HUMAN OTC DRUG
Nonproprietary name
ammonia
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Direct Outlet Supplier LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-11-27
Substance
AMMONIA
Active strength
15 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
ammonia inhalants
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIA15 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5138Q19F1XInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93eced19-297b-4df9-8f0d-20856ba47910Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85813-003-01ammonia inhalants0.3 mL in 1 AMPULEINHALANT0.31
85813-003-01ammonia inhalants50 in 1 BOXINHALANT501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299889ammonia 15 % Nasal InhalantPSN93eced19-297b-4df9-8f0d-20856ba479101
1299889ammonia 150 MG/ML Nasal InhalantSCD93eced19-297b-4df9-8f0d-20856ba479101
1299889ammonia 0.045 GM per 0.3 ML Nasal InhalantSY93eced19-297b-4df9-8f0d-20856ba479101
1299889ammonia 0.3 ML Nasal InhalantSY93eced19-297b-4df9-8f0d-20856ba479101
1299889ammonia 15 % Nasal InhalantSY93eced19-297b-4df9-8f0d-20856ba479101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85813-003-018581300030150 AMPULE in 1 BOX (85813-003-01) / .3 mL in 1 AMPULE50 ampule2025-11-27NoNoCurrent
85813-003-028581300030250 AMPULE in 1 JAR (85813-003-02) / .3 mL in 1 AMPULE50 ampule2026-11-02NoNoCurrent