FDA.reportPublic FDA data

Benadryl

Product NDC
29485-7963
Requested package NDC
29485-7963-2
11-digit product format
294857963
Labeler code
29485
Product ID
29485-7963_e3b61c1f-5412-5e33-e053-2995a90a0f61
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mechanical Servants, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-19
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage29485-796329485-7963-2DDiscontinued by firm2026-10-12

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 INGREDIENTTC2D6JAD40BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
DiphenhydramineACTIVE MOIETY8GTS82S83MBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
D&C red no. 27INACTIVE INGREDIENT2LRS185U6KBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ABENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-7963BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]14Legacy NDC20231207_53de0882-12ad-4c5c-bdb8-85d40d1da5e6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29485-7963-22948579630225 POUCH in 1 BOX (29485-7963-2) > 2 TABLET, FILM COATED in 1 POUCH25 pouch2020-07-100000-00-00NoNoCurrent