equate pain and fever

Product NDC
49035-946
11-digit product format
490350946
Labeler code
49035
Product ID
49035-946_dbaf8d52-5060-4d2e-8b1f-663ca06cb847
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
2011-08-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage49035-94649035-946-10DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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 pain and fever
Brand name suffix
infants
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
8a152c8d-8ae0-4201-8bb9-7b22c3577415Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-946-10equate pain and feverinfants30 mL in 1 BOTTLESUSPENSION306
49035-946-10equate pain and feverinfants1 in 1 CARTONSUSPENSION16
49035-946-16equate pain and feverinfants1 in 1 CARTONSUSPENSION16
49035-946-16equate pain and feverinfants59 mL in 1 BOTTLESUSPENSION596

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-946-10ML - Milliliter49035-9460b63dd65-e435-48b2-a06f-39e72bd246d512013-02-13
49035-946-16ML - Milliliter49035-9460456c2f1-54cb-495c-8ad2-a56d16c93c2d12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-946EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20240719_8a152c8d-8ae0-4201-8bb9-7b22c3577415.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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
application number: M013
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 32 MG/ML Oral SuspensionSCD8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668APAP 32 MG/ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-946-10490350946101 BOTTLE in 1 CARTON (49035-946-10) > 30 mL in 1 BOTTLE1 bottle2011-09-140000-00-00NoNoCurrent
49035-946-16490350946161 BOTTLE in 1 CARTON (49035-946-16) / 59 mL in 1 BOTTLE1 bottle2011-08-080000-00-00NoNoCurrent