Home NDC 17856-0604 Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Product NDC 17856-0604
11-digit product format 178560604
Labeler code 17856
Product ID 17856-0604_bdc594a6-ff16-4cf7-bcc8-119738fd7edd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA088864
Marketing category ANDA
Marketing start 1985-01-04
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength 15 mg/5mL; mg/5mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS], 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-0604-4 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0604-4 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0604-4 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-0604-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-0604-5 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-0604-5 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 17856-0604-5 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 17856-0604-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-0604-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088864-001 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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0604-4 Dextromethorphan Hydrobromide and Promethazine Hydrochloride 72 in 1 BOX SYRUP 72 5 17856-0604-5 Dextromethorphan Hydrobromide and Promethazine Hydrochloride 5 mL in 1 CUP SYRUP 5 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0604 DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.] 5 Legacy NDC, 2 package rows 20240606_ba7ad7f8-3261-4977-a13a-f6e07c510a9a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17856-0604-4 17856060404 72 CUP in 1 BOX (17856-0604-4) > 5 mL in 1 CUP (17856-0604-5) 72 cup 2022-06-08 0000-00-00 No No Current 17856-0604-5 17856060405 5 mL in 1 CUP 5 ml Historical