Home NDC 67751-215-01 Handy Solutions Headache Pain Relief
Product NDC 67751-215
Requested package NDC 67751-215-01
11-digit product format 677510215
Labeler code 67751
Product ID 67751-215_1626df04-bddf-e345-e063-6394a90a6fcc
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Navajo Manufacturing Company Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-23
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67751-215 67751-215-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Handy Solutions Headache Pain Relief
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 250 mg/1 ACETAMINOPHEN 250 mg/1 ASPIRIN 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup 362O9ITL9D Internal UNII lookup R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308297 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67751-215-01 Handy Solutions Headache Pain Relief 2 in 1 PACKET TABLET, FILM COATED 2 2 67751-215-01 Handy Solutions Headache Pain Relief 2 in 1 CARTON TABLET, FILM COATED 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67751-215 HANDY SOLUTIONS HEADACHE PAIN RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240417_e5481abe-6971-2bc5-e053-2995a90ae895.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67751-215-01 67751021501 2 PACKET in 1 CARTON (67751-215-01) / 2 TABLET, FILM COATED in 1 PACKET 2 packet 2021-09-23 0000-00-00 No No Current