Kids Pain and Fever

Product NDC: 69676-0089
11-digit product format: 696760089
Labeler code: 69676
Product ID: 69676-0089_35d00d8c-b098-0878-e063-6294a90a5af9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: LIQUID
Route: ORAL
Labeler: Genexa Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-13
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69676-0089-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69676-0089-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69676-0089-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69676-0089-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69676-0089-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69676-0089-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69676-0089-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Kids Pain and Fever
Listing expiration: 2027-12-31

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
fcffa7e6-145c-6bc0-e053-6294a90a4751	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69676-0089-9	2025-05-23	C162847	48780-1	2cef2736-822e-d83d-e063-dadaa90ab31f	Kids' Pain & Fever Organic Cherry Flavor (2 Pack)
69676-0089-9	2025-01-30	C162847	48780-1	2cef2736-822e-d83d-e063-dadaa90ab31f	Kids' Pain & Fever Organic Cherry Flavor (2 Pack)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69676-0089-9	Kids Pain and Fever	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		2
69676-0089-9	Kids Pain and Fever	2 in 1 CARTON	LIQUID	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69676-0089	KIDS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [GENEXA INC.]	2	Current NDC, 2 package rows	20250525_fcffa7e6-145c-6bc0-e053-6294a90a4751.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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Relief Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	United Natural Foods, Inc. dba UNFI	807598ef-9f03-48df-b076-3ee95ef4b06c	2026-01-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength, Non-Aspirin	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1fb5e871-45fd-46fe-bf73-5192f8316e8e	2026-01-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Valu Merchandisers Company	0005aafa-08f8-4990-a54d-cc097195708f	2026-01-02	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	Walmart Inc.	152bb455-da5b-ae13-e063-6394a90acab0	2026-01-01	Warnings	Exact identifier application number: M013
Dr. Cocoa for Children Pain and Fever	ACETAMINOPHEN	Infirst Healthcare Inc.	486ea294-6d18-a907-e063-6294a90ad284	2026-01-01	Warnings	Exact identifier application number: M013
ED APAP	ACETAMINOPHEN	EDWARDS PHARMACEUTICALS, INC.	f76d5fff-ebea-40f9-aad3-4064a0c863f0	2025-12-31	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	99ec63ef-aa28-c2fb-e053-2a95a90a9f6d	2025-12-31	Warnings	Exact identifier application number: M013
Puregen Labs Acetaminophen	ACETAMINOPHEN	Advanced Rx LLC	474580af-f6b0-e440-e063-6394a90aaada	2025-12-31	Warnings	Exact identifier application number: M013
Liquid Acetaminophen	ACETAMINOPHEN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	2025-12-31	Warnings	Exact identifier application number: M013
Llorens Care Children Acetaminophen	ACETAMINOPHEN	Llorens Pharmaceutical International Division, Inc.	2a46d7d2-293b-5024-e063-6294a90a31aa	2025-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)	Walgreens	3a801457-c5d0-b134-e063-6294a90ac5cb	2025-12-31	Warnings	Exact identifier application number: M013
Daytime and Nighttime Severe Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Genexa Inc.	190c7eaf-dcd4-d314-e063-6294a90a6f33	2025-12-30	Warnings	Exact identifier application number: M013
BioElectro Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Genomma Lab USA	683a0fba-921c-48e7-a391-180c04f0d1c4	2025-12-30	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	0181af13-da32-4431-be39-c31fdfac9202	2025-12-29	Warnings	Exact identifier application number: M013
Gemma Cut the Cramp	ASPIRIN, CAFFEINE	Rally Labs LLC	16c9a296-077a-8e12-e063-6294a90a1b8b	2025-12-29	Warnings	Exact identifier application number: M013
Blowfish	ASPIRIN, CAFFEINE	Rally Labs LLC	0d3798bc-04ef-584e-821b-7aa76036b7d1	2025-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	ad29a37f-39a2-5c84-e053-2995a90a2f39	2025-12-29	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Pioneer Life Sciences, LLC	ac9efd62-8fee-b777-e053-2995a90a3783	2025-12-29	Warnings	Exact identifier application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry	ACETAMINOPHEN	Puro Pharma Inc.	a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009	2025-12-27	Warnings	Exact identifier application number: M013
Cystex PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Clarion Brands, LLC	9668a2ca-729e-4172-80b5-33e6c5175ba4	2025-12-27	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	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	fcffa7e6-145c-6bc0-e053-6294a90a4751	2
307668	APAP 32 MG/ML Oral Suspension	SY	fcffa7e6-145c-6bc0-e053-6294a90a4751	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69676-0089-9	69676008909	2 BOTTLE, PLASTIC in 1 CARTON (69676-0089-9) / 118 mL in 1 BOTTLE, PLASTIC	2025-03-13	No	No	Current