Tetracaine
- Product NDC
- 71888-103
- 11-digit product format
- 718880103
- Labeler code
- 71888
- Product ID
- 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tetracaine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bellus Medical, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-01
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 20 mg/1000mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- 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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 71888-103-02 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 71888-103-02 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 71888-103-02 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 71888-103-02 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 71888-103-02 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 71888-103-02 | 9bebd1f3094a… | 5416666fcb17… |
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
- Tetracaine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TETRACAINE HYDROCHLORIDE | 20 mg/1000mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5NF5D4OPCI | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60cabb5f-606b-7a74-e053-2a91aa0ac024 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a26f29b9-6919-4f09-a354-491df8d2b97d | Product name | 1 | 20251021 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 122d1fa8-7b9e-49b4-89ce-b062ffd1d947 | Product name | 1 | 20181030 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-10-27 | 2% Tetracaine Gel |
| 2023-10-27 | 2% Tetracaine Gel |
| 2020-01-31 | 2% Tetracaine Gel |
| 2020-01-31 | 2% Tetracaine Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71888-103-01 | Tetracaine | 4 mL in 1 PACKET | GEL | 4 | 4 | |
| 71888-103-02 | Tetracaine | 12 in 1 BOX | GEL | 12 | 4 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| equaline anti itch maximum strength | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 070000d7-7d4d-439b-9a91-851ba7c027e6 | 2024-10-03 | Warnings | M017 |
| hydrocortisone anti itch | HYDROCORTISONE | H E B | a1a9fed8-4938-48b5-81f1-d3942d534bb8 | 2024-10-03 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | ef9ea069-9b97-4bf5-aaac-deb85334dbd0 | 2024-10-03 | Warnings | M017 |
| Basic Care Hydrocortisone | HYDROCORTISONE | Amazon.com Services LLC | 7fa13ab4-5f2d-4a48-816f-1b22d5f757b2 | 2024-10-03 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | dc388dc1-0c4f-4bf1-8a12-fa39892317bc | 2024-10-02 | Warnings | M017 |
| Geliga Muscular | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | fb2beb08-0ad6-a89d-e053-6294a90aa6fe | 2024-10-02 | Warnings | M017 |
| Geliga Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | da28097f-4b5c-6159-e053-2a95a90a7d96 | 2024-10-02 | Warnings | M017 |
| Circatrix | CAPSAICIN | PureTek Corporation | cd3b1256-2df8-dc26-e053-2a95a90ad049 | 2024-10-02 | Warnings | M017 |
| DermacinRx Penetral Cream | CAPSAICIN | PureTek Corporation | 1e343a52-6071-3230-e054-00144ff8d46c | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 36abfc2c-d424-4df8-968d-866342c96a56 | 2024-10-02 | Warnings | M017 |
| Eagle Balm | CAMPHOR MENTHOL | Eagle Indo Pharma, PT | 87614869-9675-2c76-e053-2a95a90a48a9 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | d9a93daa-4e24-6690-e053-2a95a90a147c | 2024-10-02 | Warnings | M017 |
| Eagle Extra Strength | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | c62a4313-2c07-5f58-e053-2995a90a083a | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | e272ec90-3cd9-5b70-e053-2a95a90a1df4 | 2024-10-02 | Warnings | M017 |
| RUGBY HYDROCORTISONE WITH ALOE | HYDROCORTISONE | A-S Medication Solutions | b2674075-aaa4-4c77-bcaa-a76336b3c321 | 2024-10-02 | Warnings | M017 |
| Herb Street Anti-Itch Stick | HYDROCORTISONE | Balassa Laboratories Inc. | 8717faae-59c3-4c6f-9ef1-285c0d2445ed | 2024-10-01 | Warnings | M017 |
| Herb Street Backache and Sore Muscle Relief | MENTHOL | Balassa Laboratories Inc. | aeac1b64-8689-4b3d-a41c-db41061257b5 | 2024-10-01 | Warnings | M017 |
| Herb Street Arthritis Relief | MENTHOL/CAMPHOR | Balassa Laboratories Inc. | a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 | 2024-10-01 | Warnings | M017 |
| Lido King Lidocaine 4% Pain Relieving Gel-Patch | LIDOCAINE | Galaxy Bio, Inc. | 2243734a-4ea2-a5e5-e063-6294a90aba15 | 2024-10-01 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71888-103-01 | 71888010301 | 4 mL in 1 PACKET | 4 ml | Historical | |||
| 71888-103-02 | 71888010302 | 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01) | 12 packet | 2017-06-01 | No | No | Current |