FDA.reportPublic FDA data

Temp X

Product NDC
69729-047
Requested package NDC
69729-047-02
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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd2edc32-0351-c991-e053-6294a90ab4ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-047-02Temp X60 mL in 1 BOTTLESUSPENSION606
69729-047-04Temp X118 mL in 1 BOTTLESUSPENSION1185
69729-047-04Temp X1 in 1 CARTONSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-047ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC]5Current NDC, Legacy NDC, 1 package rows20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.zip
69729-047TEMP X (ACETAMINOPHEN) SUSPENSION [OPMX CHULA VISTA]5Current NDC, Legacy NDC, 2 package rows20241116_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 49 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENMajor Pharmaceuticals38b839b6-de7d-4f33-a19a-efc92cdad92c2025-01-24WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
application number: M013
Safety Coated Aspirin 81 mg Low DoseASPIRIN 81MGUlai Health LLC3d225a11-a53b-4dc2-9c25-13cab007900f2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCc9d3cee1-531c-439f-ae19-07acd366aad62025-01-20WarningsExact identifier
application number: M013
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
application number: M013
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
application number: M013
StanbackASPIRIN AND CAFFEINEMedtech Products Inc.caaa1313-09e4-45aa-8836-346f6a3701962025-01-17WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
application number: M013
EcotrinASPIRINMedtech Products Inc.222d187b-aae6-410b-baeb-b2bd42f5c6762025-01-16WarningsExact identifier
application number: M013
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
application number: M013
Chewable Low Dose AspirinASPIRINTARGET CORPORATIONf934e72a-2e9f-da17-e053-6394a90a1a2e2025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 32 MG/ML Oral SuspensionSCD5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668APAP 32 MG/ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfd2edc32-0351-c991-e053-6294a90ab4ce5
307668acetaminophen 32 MG/ML Oral SuspensionSCDfd2edc32-0351-c991-e053-6294a90ab4ce5
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfd2edc32-0351-c991-e053-6294a90ab4ce5
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfd2edc32-0351-c991-e053-6294a90ab4ce5
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfd2edc32-0351-c991-e053-6294a90ab4ce5
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfd2edc32-0351-c991-e053-6294a90ab4ce5
307668APAP 32 MG/ML Oral SuspensionSYfd2edc32-0351-c991-e053-6294a90ab4ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-047-026972900470260 mL in 1 BOTTLE (69729-047-02) 60 ml2021-02-010000-00-00NoNoCurrent