FDA.reportPublic FDA data

49354-076-01

Product NDC
49354-076
Requested package NDC
49354-076-01
11-digit product format
493540076
Labeler code
49354
Product ID
49354-076_e357d094-2d29-04b3-e053-2a95a90a7f50
Type
DRUG FOR FURTHER PROCESSING
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing start
2020-12-10
Substance
SALICYLIC ACID
Active strength
170 mg/g
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage49354-07649354-076-01UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID170 mg/g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210140Compound W 17 % Topical GelPSNb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 17 % Topical GelPSNb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140salicylic acid 0.17 MG/MG Topical Gel [Compound W brand of salicylic acid]SBDb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 0.17 MG/MG Topical GelSCDb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140Compound W brand of salicylic acid 0.17 MG/MG Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
210140Compound W brand of salicylic acid 17 % Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5
312880salicylic acid 17 % Topical GelSYb55c7421-a8fe-8d4e-e053-2a95a90a7a6f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
49354-076-01493540076017 g in 1 TUBE (49354-076-01)7 g10-DEC-20Current