Home NDC 68788-9688 Diphenhydramine HCL
Product NDC 68788-9688
11-digit product format 687889688
Labeler code 68788
Product ID 68788-9688_c01dc08f-91c0-4361-98d3-56ad09bf951a
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application 341
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-01-27
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup 1049909 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-9688-1 Diphenhydramine HCL 15 in 1 BOTTLE, PLASTIC CAPSULE 15 12 68788-9688-3 Diphenhydramine HCL 30 in 1 BOTTLE, PLASTIC CAPSULE 30 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9688 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250330_3ac0beba-303d-404e-bfec-0cf8c0e8624d.zip
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-9688-1 68788968801 15 CAPSULE in 1 BOTTLE, PLASTIC (68788-9688-1) 15 capsule 2010-01-27 0000-00-00 No No Current 68788-9688-3 68788968803 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-9688-3) 30 capsule 2010-01-27 0000-00-00 No No Current