Childrens Robitussin 12 Hour Cough Relief

Product NDC: 0031-8725
11-digit product format: 000318725
Labeler code: 0031
Product ID: 0031-8725_159adf0d-831e-3d0e-e063-6394a90a40dd
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan polistirex
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: ANDA091135
Marketing category: ANDA
Marketing start: 2016-07-05
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 30 mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
A091135-001	DEXTROMETHORPHAN POLISTIREX	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL			2012-05-25

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	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091135-001	DEXTROMETHORPHAN POLISTIREX	EQ 30MG HYDROBROMIDE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2012-05-25	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Robitussin 12 Hour Cough Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373045	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
6bcad434-5714-443c-ba83-ed534df9f20a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8725-10	Childrens Robitussin 12 Hour Cough Relief	89 mL in 1 BOTTLE	SUSPENSION, EXTENDED RELEASE	89		9
0031-8725-10	Childrens Robitussin 12 Hour Cough Relief	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8725-10	ML - Milliliter	0031-8725	8171b823-c64f-4001-a73d-9d54349e6368	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8725	CHILDRENS ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [HALEON US HOLDINGS LLC]	9	Current NDC, Legacy NDC, 2 package rows	20240410_6bcad434-5714-443c-ba83-ed534df9f20a.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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
12 hr relief cough dm	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	03c44e2f-d6e3-4c78-9c9a-92d1708a62fe	2026-07-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Equate Cough DM	DEXTROMETHORPHAN POLISTIREX	Wal-Mart Stores Inc	956fcc21-9e0f-41e3-9304-f379364a7d1c	2026-06-26	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
leader childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	3a468feb-da54-4a2c-bfce-bfe99f77efc3	2026-06-25	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
CHILDRENS 12 HR COUGH RELIEF	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c	2026-06-17	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
12 HR RELIEF COUGH DM	DEXTROMETHORPHAN POLISTIREX	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d63fff6c-a1cd-4636-b1d3-ae83be40c3f7	2026-06-03	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
up and up 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Target Corporation	a8acec73-dc66-444e-9438-370893cd5129	2026-05-11	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
COUGH DM	DEXTROMETHORPHAN POLISTIREX	Safeway	58dab2f1-27b5-4522-bdc6-b710f20802eb	2026-05-04	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	Major Pharmaceuticals	cdb5616e-0f04-4b9e-a82b-994e9ba3b515	2026-04-13	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Leader Cough DM	DEXTROMETHORPHAN POLISTIREX	Cardinal Health 110, LLC. dba Leader	a07b70d0-3842-4ea6-abb4-95b4638d5e55	2026-04-08	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Rite Aid Corporation	0b92c230-e86f-4e2f-9330-6a85de61eaf0	2026-03-24	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	ce7dafc6-1c23-40d2-94d0-2568298fd7ff	2026-03-06	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
cough dm	DEXTROMETHORPHAN POLISTIREX	HyVee Inc	20c10d74-0435-4e8a-acd7-5af1f8382c28	2026-01-27	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
DG Health Cough DM	DEXTROMETHORPHAN POLISTIREX	Dolgencorp Inc	648ca6b2-d31f-4941-baad-0f2accd30a9e	2026-01-21	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	Meijer Distribution Inc	6bdfa599-7898-4c05-927c-52fb82e0e686	2026-01-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
TopCare Cough DM	DEXTROMETHORPHAN POLISTIREX	Topco Associates LLC	490f695c-e60f-43db-b3f3-a9ffbb2906dd	2025-12-10	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	db2e79f7-827f-45da-85ba-f3a774251070	2025-12-09	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
childrens cough dm	DEXTROMETHORPHAN POLISTIREX	Walgreen Company	317ab8e0-c329-4d4e-9fd0-4bff4e1504cd	2025-11-20	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
foster and thrive 12 hour cough relief	DEXTROMETHORPHAN POLISTIREX	Strategic Sourcing Services LLC	043072e5-b92d-4fed-bfd8-aea07956806b	2025-11-14	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
good sense cough dm	DEXTROMETHORPHAN POLISTIREX	L. Perrigo Company	1b11b25b-2716-45f9-830f-ddf622366e60	2025-11-02	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135
Cough DM	DEXTROMETHORPHAN POLISTIREX	H E B	f8f225cd-a0f2-4991-828f-cc7549778235	2025-11-01	Warnings	Exact identifier application applno (ANDA): 091135 application number: ANDA091135

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	6bcad434-5714-443c-ba83-ed534df9f20a	9
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	6bcad434-5714-443c-ba83-ed534df9f20a	9
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	6bcad434-5714-443c-ba83-ed534df9f20a	9
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	6bcad434-5714-443c-ba83-ed534df9f20a	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8725-10	00031872510	1 BOTTLE in 1 CARTON (0031-8725-10) / 89 mL in 1 BOTTLE	1 bottle	2016-07-05	0000-00-00	No	No	Current