ultra concentrated daytime/ nighttime severe softgel

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride softgel

Labeler: cvs pharmacy, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ultra concentrated daytime/ nighttime severe softgel
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride softgel
Labeler cvs pharmacy, inc
Dosage Form KIT
Routes
ORAL
Manufacturer
CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 51316-547
Product ID 51316-547_33d56c05-b6e7-7fa1-e063-6394a90a96ed
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316547
Hyphenated Format 51316-547

Supplemental Identifiers

RxCUI
1086997 1297288 2634363

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 ultra concentrated daytime/ nighttime severe softgel (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride softgel (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg
  • 10 mg
  • 5 mg
  • 6.25 mg
source: label
Packaging
  • 2 BLISTER PACK in 1 CARTON (51316-547-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

51316-547-24 2 BLISTER PACK in 1 CARTON (51316-547-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Ultra concentrated Daytime/ Nighttime Severe Softgel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "33d56c05-b6e7-7fa1-e063-6394a90a96ed", "openfda": {"rxcui": ["1086997", "1297288", "2634363"], "spl_set_id": ["24cedaec-06a6-8fde-e063-6394a90a3d7a"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-547-24)  / 1 KIT in 1 BLISTER PACK *  8 CAPSULE in 1 BLISTER PACK *  4 CAPSULE in 1 BLISTER PACK", "package_ndc": "51316-547-24", "marketing_start_date": "20250201"}], "brand_name": "Ultra concentrated Daytime/ Nighttime Severe Softgel", "product_id": "51316-547_33d56c05-b6e7-7fa1-e063-6394a90a96ed", "dosage_form": "KIT", "product_ndc": "51316-547", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine hydrochloride softgel", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ultra concentrated Daytime/ Nighttime Severe Softgel", "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}