Home DailyMed f06d3ff4-0b81-bd33-e053-2a95a90af7e9 Albuterol Sulfate Inhalation Solution 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 The Ritedose Corporation
Effective date 2022-12-22
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source legacy-cache
Hydrated at 2026-08-01 21:43:38 Label at a glance# Product Albuterol Sulfate Inhalation Solution
Active ingredient ALBUTEROL SULFATE
Label structure 4 sections
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 6 matching rows.
Albuterol Sulfate Inhalation Solution Albuterol Sulfate EDETATE DISODIUM SULFURIC ACID ALBUTEROL SODIUM CHLORIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 8 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 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 A214531-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 A214531-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 68 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 2026-09-14 22:38:34 2026-08 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN RS 2021-12-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2021-12-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2021-12-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2021-12-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214531-001 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2021-12-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214531-002 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2021-12-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.