Childrens Allergy

Product NDC
55301-092
Requested package NDC
55301-092-04
11-digit product format
553010092
Labeler code
55301
Product ID
55301-092_df086eb6-6369-4a7b-9341-953933304f97
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
AAFES/Your Military Exchanges
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-30
Marketing end
2023-12-29
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55301-09255301-092-04DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55301-09255301-092-04DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55301-09255301-092-04DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55301-09255301-092-04DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-092CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [AAFES/YOUR MILITARY EXCHANGES]6Legacy NDC20241212_3bd2add5-49ca-4725-ba16-507908ee3715.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-092-04553010092041 BOTTLE, PLASTIC in 1 BOX (55301-092-04) > 118 mL in 1 BOTTLE, PLASTIC2015-09-302023-12-29NoNoCurrent