Home NDC 0904-5306-61 Diphenhydramine Hydrochloride
Product NDC 0904-5306
Requested package NDC 0904-5306-61
11-digit product format 009045306
Labeler code 0904
Product ID 0904-5306_a2a395d4-45f9-9db7-e053-2995a90a6412
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-01-02
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-5306 0904-5306-61 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-5306 0904-5306-61 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-5306-24 Diphenhydramine Hydrochloride 2 in 1 CARTON CAPSULE 2 17 0904-5306-24 Diphenhydramine Hydrochloride 12 in 1 BLISTER PACK CAPSULE 12 17 0904-5306-60 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 17 0904-5306-61 Diphenhydramine Hydrochloride 10 in 1 BLISTER PACK CAPSULE 10 17 0904-5306-61 Diphenhydramine Hydrochloride 10 in 1 BOX CAPSULE 10 17 0904-5306-80 Diphenhydramine Hydrochloride 1000 in 1 BOTTLE CAPSULE 1000 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 LACTOSE INACTIVE INGREDIENT J2B2A4N98G DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] 9 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 LACTOSE INACTIVE INGREDIENT J2B2A4N98G DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIPHENHYDRAMINE HCL CAPSULE [CARDINAL HEALTH] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5306 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS] 15 Legacy NDC, 6 package rows 20250101_04e70311-6412-4a20-84e3-f6e26d5f19ab.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 0904-5306-61 00904530661 10 BLISTER PACK in 1 BOX (0904-5306-61) > 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2009-01-02 0000-00-00 No No Current