FDA.reportPublic FDA data

TENSION HEADACHE RELIEF

Product NDC
68210-4239
11-digit product format
682104239
Labeler code
68210
Product ID
68210-4239_f0fc7d8e-e635-73a3-e053-2a95a90a4566
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-12-29
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4239IInactivated by FDA2026-10-05
excluded packagepackage68210-423968210-4239-1IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4239-1TENSION HEADACHE RELIEF100 in 1 JARTABLET1004
68210-4239-1TENSION HEADACHE RELIEF1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4239TENSION HEADACHE RELIEF (ACETAMINOPHEN AND CAFFEINE) TABLET [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 2 package rows20250101_74940acc-4193-4ab4-a4e2-e4a973172ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN74940acc-4193-4ab4-a4e2-e4a973172ca54
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD74940acc-4193-4ab4-a4e2-e4a973172ca54
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY74940acc-4193-4ab4-a4e2-e4a973172ca54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4239-1682104239011 JAR in 1 CARTON (68210-4239-1) > 100 TABLET in 1 JAR1 jar2022-12-290000-00-00NoNoCurrent