Temperal-ito

Product NDC: 69729-006
11-digit product format: 697290006
Labeler code: 69729
Product ID: 69729-006_5c3f89b8-a415-d1b8-e063-6394a90aa0e3
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: 2027-12-31
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: Temperal-ito
Listing expiration: 2027-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69729-006-02	Temperal-ito	60 mL in 1 BOTTLE	SUSPENSION	60	6
69729-006-02	Temperal-ito	1 in 1 CARTON	SUSPENSION	1	6
69729-006-04	Temperal-ito	1 in 1 CARTON	SUSPENSION	1	6
69729-006-04	Temperal-ito	118 mL in 1 BOTTLE	SUSPENSION	118	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-006	TEMPERAL-ITO (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]	6	Current NDC, 4 package rows	20241116_fd2d85a0-4bc6-3ed0-e053-6294a90a8494.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 71 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	4d572228-3141-4539-9c3d-2fd06e94eee3	2024-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	1b5ff867-5442-4cf8-bd1e-530093cc88f8	2024-04-05	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier application number: M013
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	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	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6
307668	APAP 32 MG/ML Oral Suspension	SY	fd2d85a0-4bc6-3ed0-e053-6294a90a8494	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69729-006-02	69729000602	1 BOTTLE in 1 CARTON (69729-006-02) / 60 mL in 1 BOTTLE	1 bottle	2023-06-02	No	No	Current
69729-006-04	69729000604	1 BOTTLE in 1 CARTON (69729-006-04) / 118 mL in 1 BOTTLE	1 bottle	2023-06-02	No	No	Current