BENZONATATE

Product NDC: 64380-712
Requested package NDC: 64380-712-06
11-digit product format: 643800712
Labeler code: 64380
Product ID: 64380-712_53f9f0d6-4b7a-0e2e-e063-6394a90ab2c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZONATATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA091133
Marketing category: ANDA
Marketing start: 2026-05-29
Substance: BENZONATATE
Active strength: 100 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64380-712	64380-712-06	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091133-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2015-07-30
A091133-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2015-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091133-001	AA
A091133-002	AA

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091133-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091133-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091133-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091133-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091133-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091133-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091133-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091133-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091133-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091133-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091133-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091133-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091133-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091133-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091133-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091133-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091133-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091133-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091133-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091133-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091133-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091133-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091133-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091133-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091133-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091133-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091133-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091133-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091133-002	AA	1	`74a2ff9319b5…`

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: BENZONATATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZONATATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5P4DHS6ENR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197397	Internal RxNorm lookup
283417	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
89f5d18e-5ef4-42a3-bc6f-abf4f308462b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64380-712-06	2022-09-08	Benzonatate Capsules, USP
64380-712-06	2022-09-08	Benzonatate Capsules, USP
64380-712-07	2022-09-08	Benzonatate Capsules, USP
64380-712-07	2022-09-08	Benzonatate Capsules, USP
64380-712-06	2022-07-29	Benzonatate Capsules, USP
64380-712-06	2022-07-29	Benzonatate Capsules, USP
64380-712-07	2022-07-29	Benzonatate Capsules, USP
64380-712-07	2022-07-29	Benzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64380-712-06	Benzonatate	100 in 1 CONTAINER	CAPSULE	100		9
64380-712-07	Benzonatate	500 in 1 BOTTLE	CAPSULE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-712-06	EA - Each	64380-712	a3e82d97-e764-4bca-b265-265ebbcc32a9	1	2015-09-10
64380-712-07	EA - Each	64380-712	0ee82118-bae1-489e-9b16-e1d2b5021511	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-712	BENZONATATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20250311_89f5d18e-5ef4-42a3-bc6f-abf4f308462b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZONATATE	BENZONATATE	Strides Pharma Science Limited	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133 ndc (package): 64380-712-06 ndc (product): 64380-712 ndc11 (package): 64380071206
Benzonatate	BENZONATATE	AvKARE	0b50405c-d399-edcd-e063-6294a90a89c2	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	f3c2acfc-f598-50ab-e053-2a95a90a11e7	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133
Benzonatate	BENZONATATE	NCS HealthCare of KY, LLC dba Vangard Labs	6f5c19ad-d811-4196-a9c3-4f6b89626b83	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091133 application number: ANDA091133

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P4DHS6ENR	BENZONATATE	104-31-4	BENZONATATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	9
283417	benzonatate 200 MG Oral Capsule	PSN	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	9
197397	benzonatate 100 MG Oral Capsule	SCD	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	9
283417	benzonatate 200 MG Oral Capsule	SCD	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	9
197397	benzonatate 100 MG Oral Capsule	PSN	6f5c19ad-d811-4196-a9c3-4f6b89626b83	6
197397	benzonatate 100 MG Oral Capsule	SCD	6f5c19ad-d811-4196-a9c3-4f6b89626b83	6
197397	benzonatate 100 MG Oral Capsule	PSN	0b50405c-d399-edcd-e063-6294a90a89c2	2
197397	benzonatate 100 MG Oral Capsule	PSN	11c4aaf1-9749-4f67-be39-1f1272cb2463	2
197397	benzonatate 100 MG Oral Capsule	PSN	f3c277bf-6695-3e9c-e053-2a95a90a2e05	2
283417	benzonatate 200 MG Oral Capsule	PSN	0b50405c-d399-edcd-e063-6294a90a89c2	2
197397	benzonatate 100 MG Oral Capsule	SCD	0b50405c-d399-edcd-e063-6294a90a89c2	2
197397	benzonatate 100 MG Oral Capsule	SCD	11c4aaf1-9749-4f67-be39-1f1272cb2463	2
197397	benzonatate 100 MG Oral Capsule	SCD	f3c277bf-6695-3e9c-e053-2a95a90a2e05	2
283417	benzonatate 200 MG Oral Capsule	SCD	0b50405c-d399-edcd-e063-6294a90a89c2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-712-06	64380071206	100 CAPSULE in 1 CONTAINER (64380-712-06)	100 capsule	2026-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP	Strides Pharma Science Limited \| Onesource Specialty Pte. Limited	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	10
Benzonatate Capsules, USP	AvKARE	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	6
Benzonatate Capsules, USP	Redpharm Drug, Inc \| RedPharm Drug, Inc.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP	RPK Pharmaceuticals, Inc.	2023-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
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