naproxen sodium pm

Generic: diphenhydramine hydrochloride, naproxen sodium

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium pm
Generic Name diphenhydramine hydrochloride, naproxen sodium
Labeler h e b
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, naproxen sodium 220 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-264
Product ID 37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208499
Listing Expiration 2027-12-31
Marketing Start 2020-10-13

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808264
Hyphenated Format 37808-264

Supplemental Identifiers

RxCUI
1550957
UNII
TC2D6JAD40 9TN87S3A3C

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 naproxen sodium pm (source: ndc)
Generic Name diphenhydramine hydrochloride, naproxen sodium (source: ndc)
Application Number ANDA208499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

37808-264-27 1 BOTTLE in 1 CARTON (37808-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE 37808-264-60 1 BOTTLE in 1 CARTON (37808-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (25 mg/1) naproxen sodium (220 mg/1)

Linked Drug Pages (1)

naproxen sodium pm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f8e2c7c-648d-488d-bd75-b9f353ce0424", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["4281faf5-7182-404f-9f53-3d9ea0354a18"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-264-27)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "37808-264-27", "marketing_start_date": "20201013"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-264-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "37808-264-60", "marketing_start_date": "20201013"}], "brand_name": "naproxen sodium pm", "product_id": "37808-264_7f8e2c7c-648d-488d-bd75-b9f353ce0424", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "37808-264", "generic_name": "diphenhydramine hydrochloride, naproxen sodium", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "naproxen sodium pm", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA208499", "marketing_category": "ANDA", "marketing_start_date": "20201013", "listing_expiration_date": "20271231"}