dormin

Generic: diphenhydramine hydrochloride

Labeler: randob labs,ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name dormin
Generic Name diphenhydramine hydrochloride
Labeler randob labs,ltd.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Randob Labs,Ltd.

Identifiers & Regulatory

Product NDC 52412-100
Product ID 52412-100_bf433db9-4fdc-4f84-8d34-3c85ec1465bf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part338
Listing Expiration 2026-12-31
Marketing Start 1992-01-01

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 52412100
Hyphenated Format 52412-100

Supplemental Identifiers

RxCUI
1049909 1919073
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 dormin (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number part338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 CAPSULE in 1 POUCH (52412-100-02)
  • 32 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-32)
  • 72 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-72)
source: ndc

Packages (3)

52412-100-02 2 CAPSULE in 1 POUCH (52412-100-02) 52412-100-32 32 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-32) 52412-100-72 72 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-72)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Dormin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bf433db9-4fdc-4f84-8d34-3c85ec1465bf", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909", "1919073"], "spl_set_id": ["a23b5195-518e-4093-aea4-10ce96460ee2"], "manufacturer_name": ["Randob Labs,Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CAPSULE in 1 POUCH (52412-100-02)", "package_ndc": "52412-100-02", "marketing_start_date": "20160301"}, {"sample": false, "description": "32 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-32)", "package_ndc": "52412-100-32", "marketing_start_date": "19920101"}, {"sample": false, "description": "72 CAPSULE in 1 BOTTLE, PLASTIC (52412-100-72)", "package_ndc": "52412-100-72", "marketing_start_date": "19920101"}], "brand_name": "Dormin", "product_id": "52412-100_bf433db9-4fdc-4f84-8d34-3c85ec1465bf", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "52412-100", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Randob Labs,Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dormin", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "part338", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "19920101", "listing_expiration_date": "20261231"}