ammonia inhalants

Product NDC
85813-003
11-digit product format
858130003
Labeler code
85813
Product ID
85813-003_e183f8ff-f63d-4637-bd14-16ca473f1a90
Type
HUMAN OTC DRUG
Nonproprietary name
ammonia
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Direct Outlet Supplier LLC
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-27
Substance
AMMONIA
Active strength
15 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ammonia inhalants
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIA15 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5138Q19F1X
Rxcui1299889

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