Temp X

Product NDC: 69729-047
11-digit product format: 697290047
Labeler code: 69729
Product ID: 69729-047_26f62929-9f8c-7354-e063-6294a90a45b9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: OPMX Chula Vista
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-06-02
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Temp X
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd2edc32-0351-c991-e053-6294a90ab4ce	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69729-047-02	Temp X	60 mL in 1 BOTTLE	SUSPENSION	60	6
69729-047-04	Temp X	118 mL in 1 BOTTLE	SUSPENSION	118	5
69729-047-04	Temp X	1 in 1 CARTON	SUSPENSION	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-047	ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC]	5	Current NDC, Legacy NDC, 1 package rows	20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.zip
69729-047	TEMP X (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]	5	Current NDC, Legacy NDC, 2 package rows	20241116_fd2edc32-0351-c991-e053-6294a90ab4ce.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 16 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	af6fe4a9-2d18-4fed-b952-0a7866f65251	2026-04-20	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Preferred Pharmaceuticals Inc.	ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e	2026-04-20	Warnings	Exact identifier application number: M013
Parry-500mg Acetaminophen	ACETAMINOPHEN	MDC PHARMACEUTICALS LIMITED	fb07ba10-3210-41bc-9310-c952118fdcf3	2026-04-17	Warnings	Exact identifier application number: M013
Aspirin NSAID	ASPIRIN	Valu Merchandisers Company	0cc46a81-54c9-44b7-b384-79d25255eff2	2026-04-17	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Valu Merchandisers Company	99de2c41-59b0-42e7-847e-e51229c6164f	2026-04-17	Warnings	Exact identifier application number: M013
Pain and Fever Childrens	ACETAMINOPHEN	Walgreen Company	1f3e2895-5ef7-4e6a-8d2e-b805d148f980	2026-04-16	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	b297aff8-a08b-4d37-b168-800a56564cbd	2026-04-16	Warnings	Exact identifier application number: M013
Childrens Tylenol	ACETAMINOPHEN	Kenvue Brands LLC	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	2026-04-16	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	2026-04-16	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	c9e384e5-fa9b-4c75-b5e3-16eb8db662ef	2026-04-16	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	b6abfbbb-9826-4cd6-940f-3a314480a5a5	2026-04-15	Warnings	Exact identifier application number: M013
Good Sense Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	f7137fe6-582e-43a4-8302-90ca54cd1de3	2026-04-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	e13656eb-513e-411e-bdae-35ff1ba7cfc1	2026-04-13	Warnings	Exact identifier application number: M013
CareOne Acetaminophen	ACETAMINOPHEN	American Sales Company	b4f54465-3232-4685-9570-90be00876577	2026-04-12	Warnings	Exact identifier application number: M013
Childrens Pain Relief Dye free	ACTEMINOPHEN	BETTER LIVING BRANDS LLC.	41f504d1-29c4-f075-e063-6394a90ad64c	2026-04-11	Warnings	Exact identifier application number: M013
Dr. Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4f1e1f1a-44f4-2356-e063-6294a90a8cdd	2026-04-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	28413cb3-22c4-40e2-ad6b-42beb438dea3	2026-04-10	Warnings	Exact identifier application number: M013
Pain Reliever Childrens	ACETAMINOPHEN	H E B	7e43de11-d20b-4920-a04d-3c1b5d35e005	2026-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Navajo Manufacturing Company Inc.	f7e572e9-82a7-2127-e053-6394a90ab01a	2026-04-08	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	APAP 32 MG/ML Oral Suspension	SY	5b8a92c9-47c0-4438-a49d-b3878f7afd73	6
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	fd2edc32-0351-c991-e053-6294a90ab4ce	5
307668	APAP 32 MG/ML Oral Suspension	SY	fd2edc32-0351-c991-e053-6294a90ab4ce	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-047-02	69729004702	60 mL in 1 BOTTLE (69729-047-02)	60 ml	2021-02-01	0000-00-00	No	No	Current
69729-047-04	69729004704	1 BOTTLE in 1 CARTON (69729-047-04) / 118 mL in 1 BOTTLE	1 bottle	2023-06-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen - OPMX LLC \| Seaway Pharma	OPMX LLC \| Seaway Pharma	2026-09-24	HUMAN OTC DRUG LABEL	7
Temp X	OPMX Chula Vista \| Seaway Pharma	2024-11-15	HUMAN OTC DRUG LABEL	5