Signature Care Childrens Ibuprofen

Product NDC: 21130-035
11-digit product format: 211300035
Labeler code: 21130
Product ID: 21130-035_16ba2996-bec0-4caa-82c1-05d01e56fe6d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Safeway
Application: ANDA074937
Marketing category: ANDA
Marketing start: 2015-09-01
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21130-035		D	Discontinued by firm	2026-10-12
excluded package	package	21130-035	21130-035-26	D	Discontinued by firm	2026-10-12
excluded package	package	21130-035	21130-035-34	D	Discontinued by firm	2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21130-035-26	Signature Care Childrens Ibuprofen	118 mL in 1 BOTTLE	SUSPENSION	118	4
21130-035-26	Signature Care Childrens Ibuprofen	1 in 1 CARTON	SUSPENSION	1	4
21130-035-34	Signature Care Childrens Ibuprofen	1 in 1 CARTON	SUSPENSION	1	4
21130-035-34	Signature Care Childrens Ibuprofen	240 mL in 1 BOTTLE	SUSPENSION	240	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-035	SIGNATURE CARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [SAFEWAY]	4	Legacy NDC, 4 package rows	20171220_940ae28a-5813-4e9e-868e-cd0680ebc40b.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 4 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER CHILDRENS IBUPROFEN	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	913a4bd0-0784-45b4-b05e-3e7c016bbb86	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	2daee8c1-d05e-406b-af65-b81bbbaa244d	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	02889717-204c-463b-8506-4c5cf18c77d3	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Dye Free Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	eccee4c6-aa94-468a-aebd-265d7a9efb6d	2025-02-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	2457c045-0b7c-48f4-9422-11623f13d8f1	2025-01-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	efb728f2-fe74-4833-8f0c-710d833abf6e	2025-01-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	7cd838e1-85da-4510-86f0-9d8bc913e810	2025-01-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	b8f43352-f771-4722-b843-f3e29f77c7c0	2025-01-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Rexall Ibuprofen	IBUPROFEN	Dolgencorp, LLC	d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0	2023-06-06	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
DG Health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	0fd6fcca-cbfe-48af-80dd-2607b5d51b53	2022-10-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	0dec2df9-ba8b-4bc7-b617-773aa08f9273	2021-12-20	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b2a14686-6083-46a1-885c-9f7c30e9c647	2021-11-30	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	1204267a-5505-4257-837b-8902b7571347	2021-09-07	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
dg health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	ad8475b3-ace1-4a05-b927-3286a8139cb4	2021-05-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	CVS Pharmacy	60fd517d-608b-473e-8a44-eb9842459997	2020-10-22	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Proficient Rx LP	6d84ed87-b643-46e2-96d4-2052f41bd936	2020-02-01	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	H E B	e7e2b766-6d05-49e2-9e88-72454b857935	2019-12-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Care One ibuprofen childrens	IBUPROFEN	American Sales Company	703869c9-7f12-4556-a2af-8e68942834f2	2018-11-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen Childrens	IBUPROFEN	H E B	0a9a54ce-572f-4a96-922f-cc136d2d4aad	2018-06-07	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	940ae28a-5813-4e9e-868e-cd0680ebc40b	4
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	940ae28a-5813-4e9e-868e-cd0680ebc40b	4
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	940ae28a-5813-4e9e-868e-cd0680ebc40b	4
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	940ae28a-5813-4e9e-868e-cd0680ebc40b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-035-26	21130003526	1 BOTTLE in 1 CARTON (21130-035-26) > 118 mL in 1 BOTTLE	1 bottle	2015-09-01	0000-00-00	No	No	Current
21130-035-34	21130003534	1 BOTTLE in 1 CARTON (21130-035-34) > 240 mL in 1 BOTTLE	1 bottle	2017-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Better Living Brands LLC Children’s Ibuprofen Drug Facts	Safeway	2017-12-09	HUMAN OTC DRUG LABEL	4