FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
62135-774
11-digit product format
621350774
Labeler code
62135
Product ID
62135-774_499ebc74-646b-4e6d-e063-6394a90ab998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040026
Marketing category
ANDA
Marketing start
1998-09-25
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6.25 mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage62135-774-23
excluded packagepackage62135-774-47
excluded packagepackage62135-774-24
excluded packagepackage62135-774-41

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040026-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040026-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040026-001PROMETHAZINE HYDROCHLORIDE6.25MG/5MLSYRUP / ORALAA1998-09-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040026-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A040026-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040026-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040026-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040026-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040026-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040026-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040026-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040026-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040026-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040026-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040026-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040026-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040026-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040026-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040026-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040026-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040026-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040026-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040026-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040026-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040026-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040026-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040026-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040026-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040026-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040026-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040026-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040026-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040026-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040026-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040026-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040026-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040026-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040026-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040026-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040026-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040026-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040026-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040026-001AA1f41ea6bd6efb…

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
PROMETHAZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R61ZEH7I1IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992432Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ca17cd4-460e-4d54-8c53-a58a2b80e5cbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
62135-774-232025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-09-30PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-232025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-07-29PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-774-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION54
62135-774-10PROMETHAZINE HYDROCHLORIDE10 mL in 1 CUPSOLUTION104
62135-774-23PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-23PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-41PROMETHAZINE HYDROCHLORIDE120 mL in 1 BOTTLESOLUTION1204
62135-774-47PROMETHAZINE HYDROCHLORIDE473 mL in 1 BOTTLESOLUTION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-774-05ML - Milliliter62135-77450c92e2b-9e09-45ba-a355-e13a46e34cde12025-03-04
62135-774-10ML - Milliliter62135-77401f79f3d-79a8-4f33-bf9a-36051de1795f12025-03-04
62135-774-23ML - Milliliter62135-7748bb32fe0-a530-4cb1-afa4-46f41a5213e112025-03-04
62135-774-24ML - Milliliter62135-774ef63ecf3-8568-4690-83c8-d38e05ba8e3712025-03-04
62135-774-41ML - Milliliter62135-7747a928ca5-21f5-468b-9a56-b7cfce91b4ae12023-12-05
62135-774-47ML - Milliliter62135-77429586084-c3f6-49d2-9b13-b1ad57b6630a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-774PROMETHAZINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 8 package rows20250215_2ca17cd4-460e-4d54-8c53-a58a2b80e5cb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040026
application number: ANDA040026
ndc (product): 62135-774
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040026
application number: ANDA040026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-774-05621350774055 mL in 1 CUP5 mlHistorical
62135-774-106213507741010 mL in 1 CUP10 mlHistorical
62135-774-23621350774232 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) 2 tray2025-02-10NoNoCurrent
62135-774-24621350774242 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05) 2 tray2025-02-10NoNoCurrent
62135-774-4162135077441120 mL in 1 BOTTLE (62135-774-41) 120 ml2023-11-27NoNoCurrent
62135-774-4762135077447473 mL in 1 BOTTLE (62135-774-47) 473 ml2023-11-27NoNoCurrent