Childrens Ibuprofen bubblegum

Product NDC: 53041-572
11-digit product format: 530410572
Labeler code: 53041
Product ID: 53041-572_e690a788-b856-44b3-afff-bb950d1eb117
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION/ DROPS
Route: ORAL
Labeler: Guardian Drug Company
Application: ANDA210149
Marketing category: ANDA
Marketing start: 2021-10-13
Substance: IBUPROFEN
Active strength: 100 mg/5mL
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
A210149-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-08-17

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	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Ibuprofen bubblegum
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	100 mg/5mL

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
197803	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
9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	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
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
53041-572-03	Childrens Ibuprofen bubblegum	1 in 1 CARTON	SUSPENSION/ DROPS	1	2
53041-572-03	Childrens Ibuprofen bubblegum	120 mL in 1 BOTTLE	SUSPENSION/ DROPS	120	2
53041-572-04	Childrens Ibuprofen bubblegum	240 mL in 1 BOTTLE	SUSPENSION/ DROPS	240	2
53041-572-04	Childrens Ibuprofen bubblegum	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
53041-572	CHILDRENS IBUPROFEN BUBBLEGUM (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN GRAPE (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN BLUE RASPBERRY (IBUPROFEN) SUSPENSION/ DROPS CHILDRENS IBUPROFEN FRUIT (IBUPROFEN) SUSPENSION/ DROPS [GUARDIAN DRUG COMPANY]	2	Current NDC, Legacy NDC, 4 package rows	20211015_9cb92af9-a829-4f54-b8f5-4e5cb4f165b7.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Ibuprofen Bubblegum Dye Free	IBUPROFEN	CVS	2cf2f35b-5d66-e3ff-e063-6294a90a9b45	2026-06-16	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen 572	IBUPROFEN	Family Dollar Services, Inc.	1a2182df-4339-442d-9c61-98c8b01e36fa	2025-12-03	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Family Dollar Services, Inc.	137a0290-822a-842d-e063-6294a90a5c18	2025-12-03	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Dye Free Childrens Ibuprofen	IBUPROFEN	CVS	2cf2a4de-29d3-8af5-e063-6294a90a9cee	2025-05-01	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Discount Drug Mart, Inc	2d58d1c4-b864-6bb8-e063-6394a90a7117	2025-02-24	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Harris Teeter, LLC	2bb186c8-f791-5f1f-e063-6294a90a87ff	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	e210c707-2bae-44a5-93dc-459dd24fd960	2023-11-20	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	c7e59784-a338-4922-a806-98c7505957cd	2023-11-10	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	ba0baba6-a7f9-4e4c-88f7-c7fbecc61f25	2023-10-25	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen bubblegum	IBUPROFEN	Guardian Drug Company	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2021-10-13	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149 ndc (product): 53041-572
Childrens Ibuprofen	IBUPROFEN	Guardian Drug Company	694866ce-c419-4b4c-bfb2-4175703d89f1	2018-09-07	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149

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	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-572-03	53041057203	1 BOTTLE in 1 CARTON (53041-572-03) / 120 mL in 1 BOTTLE	1 bottle	2021-10-13	0000-00-00	No	No	Current
53041-572-04	53041057204	1 BOTTLE in 1 CARTON (53041-572-04) / 240 mL in 1 BOTTLE	1 bottle	2021-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guardian Children's Ibuprofen Oral Suspension	Guardian Drug Company	2021-10-13	Human OTC Drug Label	2