Allergy Relief

Product NDC
68016-640
Requested package NDC
68016-640-10
11-digit product format
680160640
Labeler code
68016
Product ID
68016-640_5452819f-c045-4d0a-8642-df227dfed473
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Chain Drug Consortium
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1990-03-15
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 packagepackage68016-64068016-640-10DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-640-10EA - Each68016-6402899ad11-f187-4574-84c7-384b92a7cb4412022-06-06
68016-640-24EA - Each68016-640d7e4be88-8a7d-4d64-8599-663a5b63c63312022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
GELATININACTIVE INGREDIENT2G86QN327LALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY REILEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-640ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE [CHAIN DRUG CONSORTIUM]13Legacy NDC20240926_26f0aa83-2191-410e-9d0d-9ff5186a8a88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-640-10680160640101 BOTTLE in 1 CARTON (68016-640-10) > 100 CAPSULE in 1 BOTTLE1 bottle1990-03-150000-00-00NoNoCurrent