Concentrated ibuprofen infants

Product NDC: 53041-637
11-digit product format: 530410637
Labeler code: 53041
Product ID: 53041-637_d0465832-f323-4ecd-a285-33a8c15eb799
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION/ DROPS
Route: ORAL
Labeler: Guardian Drug Company
Application: ANDA210755
Marketing category: ANDA
Marketing start: 2018-10-03
Substance: IBUPROFEN
Active strength: 50 mg/1.25mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210755-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			2018-09-26

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Concentrated ibuprofen infants
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	50 mg/1.25mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204442	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
3a32f0c7-c03e-4783-a429-08280993ddfb	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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	Strength	SPL version
53041-637-09	Concentrated ibuprofen infants	30 mL in 1 BOTTLE	SUSPENSION/ DROPS	30		2
53041-637-09	Concentrated ibuprofen infants	1 in 1 CARTON	SUSPENSION/ DROPS	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-637	CONCENTRATED IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [GUARDIAN DRUG COMPANY]	2	Current NDC, Legacy NDC, 2 package rows	20221202_3a32f0c7-c03e-4783-a429-08280993ddfb.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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen infants Drops	IBUPROFEN	Discount Drug Mart, Inc	2d582242-8b63-b51d-e063-6394a90a979a	2025-02-24	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Ibuprofen infants Drops	IBUPROFEN	Harris Teeter, LLC	2c39a24f-4e42-d75f-e063-6394a90a60fa	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Infants Ibuprofen	INFANTS IBUPROFEN	Family Dollar Services, Inc.	13143eb6-2fe8-487b-e063-6294a90a967e	2024-03-27	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Concentrated ibuprofen infants	IBUPROFEN	Chain Drug Marketing Association Inc.	c9ae72d8-d205-4736-9bc4-2325cd77d36b	2023-11-03	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Concentrated ibuprofen infants	IBUPROFEN	Guardian Drug Company	3a32f0c7-c03e-4783-a429-08280993ddfb	2022-11-28	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755 ndc (product): 53041-637
Concentrated ibuprofen infants	IBUPROFEN	Wal-Mart Stores, Inc.	00b7fc71-8cf0-4c12-a479-146408f7f91b	2022-01-11	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755

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
204442	ibuprofen 50 MG in 1.25 mL Oral Suspension	PSN	3a32f0c7-c03e-4783-a429-08280993ddfb	2
204442	ibuprofen 40 MG/ML Oral Suspension	SCD	3a32f0c7-c03e-4783-a429-08280993ddfb	2
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension	SY	3a32f0c7-c03e-4783-a429-08280993ddfb	2
204442	ibuprofen 50 MG per 1.25 ML Oral Suspension Drops	SY	3a32f0c7-c03e-4783-a429-08280993ddfb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-637-09	53041063709	1 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLE	1 bottle	2018-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guardian Concentrated Ibuprofen Infants Drops	Guardian Drug Company	2022-11-28	Human OTC Drug Label	2