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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier application number: M013
Family Wellness Pain Reliever	ASPIRIN	FAMILY WELLNESS SERVICES, INC.	075e19f4-1a58-aedd-e063-6294a90af708	2024-11-20	Warnings	Exact identifier application number: M013
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier application number: M013
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier application number: M013 ndc (product): 69729-047
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier application number: M013
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier application number: M013
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier application number: M013
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier application number: M013
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier application number: M013
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier application number: M013
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier application number: M013
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	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