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 |
|---|---|---|---|---|---|---|
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | M017 |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | M017 |
| Terramed Just Think Comfort Hydrocortisone 1% Cream | HYDROCORTISONE | Rida LLC | 0d2c0c2c-370f-4adb-b0ea-1e218c927f8b | 2026-09-01 | Warnings | M017 |
| Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | HyVee Inc | 53157137-b980-45d2-aa10-8c111c0ec2f4 | 2026-08-31 | Warnings | M017 |
| EAYONYUMT NECK PAIN RELIEF | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a450e68-07a7-a4bb-e063-6294a90a97c9 | 2026-08-30 | Warnings | M017 |
| EAYONYUM BACK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a458280-4f9c-5af6-e063-6394a90acb2e | 2026-08-30 | Warnings | M017 |
| EAYONYUM KNEE PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a45d19f-c753-71eb-e063-6294a90a4805 | 2026-08-30 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin | HYDROCORTISONE | AmerisourceBergen | c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495 | 2026-08-30 | Warnings | M017 |
| Olu Pain Management | LIDOCAINE AND CAMPHOR | HAWAII REPACK, INC. | 31ed3d82-ba12-46b2-b0ec-7e5e019efc10 | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a177987-7c05-f07f-e063-6394a90aa9ba | 2026-08-28 | Warnings | M017 |
| Relieved Pro Wrap | 4% LIDOCAINE PATCH | Transfer Technology | 5a1c6ebf-ad3f-c47b-e063-6294a90aa19a | 2026-08-28 | Warnings | M017 |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | M017 |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a16c6aa-3ab0-3e46-e063-6294a90a6d8f | 2026-08-27 | Warnings | M017 |
| Lidocaine Patch 4% | LIDOCAINE 4% | Global America Group LLC | 1eec782d-0e56-43d2-b842-da0ae47c5dc9 | 2026-08-26 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd | 0f928b5b-60f5-4a45-a409-c601eb330487 | 2026-08-26 | Warnings | M017 |
| PARCHE CALIENTE | CAPSAICINA AND MENTOL | DW SUPPORT LLC | 59f2708e-295a-ccb3-e063-6394a90ad395 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief | LIDOCAINE | CVS Pharmacy | 4ecbc263-e0d4-18d5-e063-6294a90a72e9 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief Lidocaine XL | LIDOCAINE | CVS Pharmacy | 4aa286e3-e274-8095-e063-6394a90ae871 | 2026-08-26 | Warnings | M017 |
| TERAPIA DE DIA Y NOCHE | PAIN RELIEVING PATCH | DW SUPPORT LLC | 59f44135-865b-9d7d-e063-6294a90a9dd9 | 2026-08-26 | 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 |