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 50 mg/1

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 35916-0438
Product ID 35916-0438_47c5b5fc-5f4a-cd15-e063-6294a90a45aa
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2027-12-31
Marketing Start 2024-01-10

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 359160438
Hyphenated Format 35916-0438

Supplemental Identifiers

RxCUI
1020477
UPC
0335916043811
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 M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0438-1)
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0438-3)
source: ndc

Packages (2)

35916-0438-1 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0438-1) 35916-0438-3 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0438-3)

Ingredients (1)

diphenhydramine hydrochloride (50 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": "47c5b5fc-5f4a-cd15-e063-6294a90a45aa", "openfda": {"upc": ["0335916043811"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["0e45d0e8-3741-7cee-e063-6394a90a2de5"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0438-1)", "package_ndc": "35916-0438-1", "marketing_start_date": "20240111"}, {"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0438-3)", "package_ndc": "35916-0438-3", "marketing_start_date": "20250301"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "35916-0438_47c5b5fc-5f4a-cd15-e063-6294a90a45aa", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "35916-0438", "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": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240110", "listing_expiration_date": "20271231"}