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 |
|---|---|---|---|---|---|---|
| CVS Health Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE | Natural Essentials, Inc. | f7198485-3d68-41d2-b9b9-f932a0649310 | 2024-12-04 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | 364924d3-fac3-4f4e-9b40-decd4ec48245 | 2024-12-03 | Warnings | M017 |
| Bite and Itch | DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE | Weeks & Leo Co., Inc. | 0a4d471b-c3f3-0a6a-e063-6394a90ad57b | 2024-12-03 | Warnings | M017 |
| Menthol | AMISH ORIGINS MEDICATED | Amish Origins LLC | 547abe39-3af3-4d70-99dd-caf8d67feda2 | 2024-12-03 | Warnings | M017 |
| Meijer Small Cold-Hot Medicated Patches | MENTHOL | Meijer Distribution Inc | be6012d6-2062-45ba-8fc4-abf14cff5845 | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | acdd5622-a9a7-4cc3-877e-57efea23303f | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5 | 2024-12-03 | Warnings | M017 |
| Salonpas DEEP Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu America, Inc. | a4ddb2b9-d023-4c8c-9285-93d51f93207d | 2024-12-03 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | ea5b4a7f-d47d-4dbd-9288-c01329e387e5 | 2024-12-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief - Overnight | LIDOCAINE | Telebrands Corp | 1030d478-6805-6579-e063-6294a90a0c76 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Cold Sore Treatment | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 82edaef0-0709-4ae1-a664-c9c5adb91ee1 | 2024-12-02 | Warnings | M017 |
| Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On | THERMACARE CAPSAICIN ROLL ON | Clarion Brands LLC | 2850f7e7-41dd-f5f9-e063-6394a90ae519 | 2024-12-02 | Warnings | M017 |
| BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 2ec1cf79-c341-4b79-9047-ce29f0dff419 | 2024-11-29 | Warnings | M017 |
| TheraCare Pain Relieving Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 242204d3-efc7-f7a9-e063-6294a90a5af1 | 2024-11-27 | Warnings | M017 |
| Walgreens Flexible Pain Relieving Lidocaine | LIDOCAINE, MENTHOL | Walgreen Co. | 6f070fa3-a61a-4523-a470-ab58bf9400a3 | 2024-11-27 | Warnings | M017 |
| Benadryl Original Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 920c50cb-9bdd-4a36-bb3d-c2559db73327 | 2024-11-26 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 884907a8-c884-4cce-ac10-9d4848fdba3e | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 7f067e95-e01c-4b9a-a02e-0af097beb18c | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 9ece9b3a-0092-4c1c-a913-c2fefcd70541 | 2024-11-22 | 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 |