FDA.reportPublic FDA data

smelling salts

Product NDC
85765-003
11-digit product format
857650003
Labeler code
85765
Product ID
85765-003_3e7d9782-4551-9f08-e063-6294a90a4f35
Type
HUMAN OTC DRUG
Nonproprietary name
Ammonia
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Shenzhen Ze'ai Electronic Co., Ltd.
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
AMMONIA
Active strength
.15 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct85765-003IInactivated by FDA2026-08-11
excluded packagepackage85765-00385765-003-01IInactivated by FDA2026-08-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85765-003-01smelling salts50 g in 1 BOTTLEINHALANT504

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 1 of 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OTTFFSS SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4e76504b-82da-e7a4-e063-6294a90a4f812026-07-30WarningsExact identifier
application number: M011
REINREUDE SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4c29c7f0-0d34-40bd-e063-6294a90a6ca72026-07-24WarningsExact identifier
application number: M011
SERYNTH SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4a4be985-7de7-4eba-e063-6394a90ac84e2026-07-21WarningsExact identifier
application number: M011
Lepnuns SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD497f5bd0-b913-706b-e063-6394a90abf302026-07-20WarningsExact identifier
application number: M011
WXMX Smelling SaltsAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49927820-1862-4792-e063-6294a90acf9e2026-07-20WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEGeiss, Destin & Dunn Inc.a4c796a8-6685-4214-bf08-10ee2735ea122026-07-09WarningsExact identifier
application number: M011
HYMYYXGS SMELLING SALTSAMMONIA 15% SMELLING SALTSWenzhou Yuyuan Pharmaceutical Co., Ltd.55edceb9-4c86-df99-e063-6294a90a79622026-07-06WarningsExact identifier
application number: M011
LAIOACDL SMELLING SALTSAMMONIA 15% SMELLING SALTSWenzhou Yuyuan Pharmaceutical Co., Ltd.55c5c8cc-f1f6-b4e4-e063-6294a90a8b8e2026-07-04WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-06-30WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEUnited Natural Foods, Inc. dba UNFI1357eade-f1d3-4df2-8a8a-4c318aab11412026-06-15WarningsExact identifier
application number: M011
Unikinesys SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5044b726-eeb4-0e21-e063-6394a90aeaa62026-06-14WarningsExact identifier
application number: M011
BOTASUN SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49aa685f-ced5-4da3-e063-6394a90a03c32026-06-14WarningsExact identifier
application number: M011
THITFAM SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD53f0636e-5293-b07d-e063-6294a90a0b672026-06-10WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEWal-Mart Stores Inc5f5b65a2-4db7-4c8e-a954-95611a0872172026-06-08WarningsExact identifier
application number: M011
TideFresh SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5363f670-9e77-ec37-e063-6394a90acb4a2026-06-03WarningsExact identifier
application number: M011
smelling salts SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD52c56483-e9d4-48f5-e063-6294a90a29092026-05-26WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-05-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEShield Pharmaceuticals Corp82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c2026-05-18WarningsExact identifier
application number: M011
Rhinoost SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5004eac7-3a8f-7fc9-e063-6294a90a26d52026-05-17WarningsExact identifier
application number: M011
AlertCAFFEINEDOLGENCORP, LLC9e47eed8-4d0f-4a26-b761-578fb593f0252026-05-06WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299889ammonia 15 % Nasal InhalantPSN38c57576-e2c1-c447-e063-6394a90a62ae4
1299889ammonia 150 MG/ML Nasal InhalantSCD38c57576-e2c1-c447-e063-6394a90a62ae4
1299889ammonia 0.045 GM per 0.3 ML Nasal InhalantSY38c57576-e2c1-c447-e063-6394a90a62ae4
1299889ammonia 0.3 ML Nasal InhalantSY38c57576-e2c1-c447-e063-6394a90a62ae4
1299889ammonia 15 % Nasal InhalantSY38c57576-e2c1-c447-e063-6394a90a62ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85765-003-018576500030150 g in 1 BOTTLE (85765-003-01) 50 g2025-06-30NoNoHistorical