TENSION HEADACHE RELIEF

Product NDC: 68210-0190
Requested package NDC: 68210-0190-2
11-digit product format: 682100190
Labeler code: 68210
Product ID: 68210-0190_ee8b53ae-4502-651f-e053-2a95a90ab4dd
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: 2018-04-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68210-0190	68210-0190-2	I	Inactivated by FDA		2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-0190-2	2025-01-30	C162847	48780-1	2cef2736-7c8a-d83d-e063-dadaa90ab31f	VALUMEDS™ TENSION HEADACHE RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-0190-2	TENSION HEADACHE RELIEF	24 in 1 BOTTLE, PLASTIC	TABLET	24		5
68210-0190-2	TENSION HEADACHE RELIEF	1 in 1 CARTON	TABLET	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0190	TENSION HEADACHE RELIEF (ACETAMINOPHEN AND CAFFEINE) TABLET [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 2 package rows	20231208_e135f7f0-e534-4266-b2fb-7f5175e36ebe.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	PSN	e135f7f0-e534-4266-b2fb-7f5175e36ebe	5
307686	acetaminophen 500 MG / caffeine 65 MG Oral Tablet	SCD	e135f7f0-e534-4266-b2fb-7f5175e36ebe	5
307686	APAP 500 MG / Caffeine 65 MG Oral Tablet	SY	e135f7f0-e534-4266-b2fb-7f5175e36ebe	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-0190-2	68210019002	1 BOTTLE, PLASTIC in 1 CARTON (68210-0190-2) > 24 TABLET in 1 BOTTLE, PLASTIC	2018-04-10	0000-00-00	No	No	Current