Home DailyMed 0a9b26e5-c31c-41a9-addd-9ce9a7878dc0 Promethazine hydrochloride Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Northwind Pharmaceuticals
Effective date 2014-05-21
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source legacy-cache
Hydrated at 2026-08-02 01:36:08 Label at a glance# Product Promethazine hydrochloride
Active ingredient PROMETHAZINE HYDROCHLORIDE
Label structure 1 sections
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-588 PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS] 1 Legacy NDC 20140527_0a9b26e5-c31c-41a9-addd-9ce9a7878dc0.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I 1 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 2 matching rows.
Promethazine hydrochloride PROMETHAZINE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 1 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040596-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 A040596-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 A040596-003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040596-002 PROMETHAZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2005-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040596-003 PROMETHAZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2005-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040596-001 PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AB 2005-11-18 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.