FDA.reportPublic FDA data

Equate Childrens Pain and Fever

Product NDC
49035-313
Requested package NDC
49035-313-34
11-digit product format
490350313
Labeler code
49035
Product ID
49035-313_ad8592d4-9344-4cfd-a721-9383cbcc4f77
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-31349035-313-34DDiscontinued by firm2026-10-27

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
Equate Childrens Pain and Fever
Listing expiration
2027-12-31

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
40eedfe9-54e1-40a2-b4a2-55ff708b89cdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-313-26Equate Childrens Pain and Fever1 in 1 CARTONSUSPENSION19
49035-313-26Equate Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1189
49035-313-34Equate Childrens Pain and Fever2 in 1 CARTONSUSPENSION29
49035-313-34Equate Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-313-26ML - Milliliter49035-313a2495bae-3e35-4fc7-97e7-876cc76bf46a12018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XEQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-313EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]8Current NDC, Legacy NDC, 4 package rows20240920_40eedfe9-54e1-40a2-b4a2-55ff708b89cd.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 59 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health pain reliefACETAMINOPHENDolgencorp Inc2e1470f5-e88f-4d1d-a308-170f7080387e2024-10-17WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART146c735b-5081-4de4-9025-d939d560bbba2024-10-17WarningsExact identifier
application number: M013
Chewable AspirinASPIRINDISCOUNT DRUG MARTc8483d64-874c-3056-e053-2995a90ad8aa2024-10-17WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINDISCOUNT DRUG MARTc8484998-e0e1-ffce-e053-2995a90aa7de2024-10-17WarningsExact identifier
application number: M013
Adult Low Strength AspirinASPIRINDISCOUNT DRUG MART9196e6de-432a-4f1c-b09b-226e4717c87c2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI1462b308-a6a5-49ca-ab29-cacbf62caf0b2024-10-17WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf3db8598-fe0e-4c53-a023-5f5f8f002cc62024-10-17WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIf86a11af-6d3c-4638-870d-a663ddf493712024-10-17WarningsExact identifier
application number: M013
Acetaminophen Gelcaps Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI3588a3ef-a493-43ed-96e0-c259f0d087db2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLCa2186895-944b-48cb-b3c2-eac208866c342024-10-17WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC6a5d43c8-f4b7-4447-b2e1-53eb12208ef02024-10-17WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC32cc6e05-84c1-4710-bebc-cb6e7133dc542024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINSTRATEGIC SOURCING SERVICES LLC2ca87a29-1f54-4da4-a66f-3b3dd4f0396c2024-10-17WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENSTRATEGIC SOURCING SERVICES LLC9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e2024-10-17WarningsExact identifier
application number: M013
AspirinASPIRINKroger Company453f62d5-f580-4d19-bfae-4f78c2a6b6d62024-10-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA Store Inc.ec6add55-f4a3-7818-e053-2a95a90aee042024-10-16WarningsExact identifier
application number: M013
ASPIRINASPIRINFSA Store Inc.062e7b7b-d052-82b0-e063-6294a90a7cce2024-10-16WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.f4322f34-ac19-371e-e053-2a95a90ac8642024-10-16WarningsExact identifier
application number: M013
Low dose Chewable AspirinASPIRINFSA STORE INC.f939b44c-93b6-ca61-e053-6394a90ae5862024-10-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART850b5ad8-8774-413c-ae38-022215a94f952024-10-16WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668acetaminophen 32 MG/ML Oral SuspensionSCD40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY40eedfe9-54e1-40a2-b4a2-55ff708b89cd9
307668APAP 32 MG/ML Oral SuspensionSY40eedfe9-54e1-40a2-b4a2-55ff708b89cd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-313-34490350313342 BOTTLE in 1 CARTON (49035-313-34) > 118 mL in 1 BOTTLE2 bottle2013-12-080000-00-00NoNoCurrent