diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: softgel healthcare private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler softgel healthcare private limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 35916-0435
Product ID 35916-0435_47c5aec7-d2eb-a728-e063-6294a90a6b53
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2023-08-07

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160435
Hyphenated Format 35916-0435

Supplemental Identifiers

RxCUI
1049909
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1)
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0435-3)
  • 2 POUCH in 1 BOX (35916-0435-4) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0435-5) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (4)

35916-0435-1 3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1) 35916-0435-3 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0435-3) 35916-0435-4 2 POUCH in 1 BOX (35916-0435-4) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0435-5 2 BAG in 1 BOX (35916-0435-5) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

DIPHENHYDRAMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47c5aec7-d2eb-a728-e063-6294a90a6b53", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["0203d919-dc1f-cca0-e063-6394a90aa1aa"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1)", "package_ndc": "35916-0435-1", "marketing_start_date": "20230807"}, {"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0435-3)", "package_ndc": "35916-0435-3", "marketing_start_date": "20250422"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0435-4)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0435-4", "marketing_start_date": "20250611"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0435-5)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0435-5", "marketing_start_date": "20260124"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "35916-0435_47c5aec7-d2eb-a728-e063-6294a90a6b53", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "35916-0435", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "SOFTGEL HEALTHCARE PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230807", "listing_expiration_date": "20271231"}