Cream
- Product NDC
- 61354-051
- Requested package NDC
- 61354-051-23
- 11-digit product format
- 613540051
- Labeler code
- 61354
- Product ID
- 61354-051_bd0b2605-e02c-10f6-e053-2995a90ab68d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- OXYGEN DEVELOPMENT, LLC
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-03-05
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 4 mg/100mg; mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 61354-051 | 61354-051-23 | I | Inactivated by FDA | 2026-10-05 |
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.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-051-03 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 4 | |
| 61354-051-03 | Cream | 1 in 1 CARTON | LOTION | 1 | 4 | |
| 61354-051-21 | Cream | 1 in 1 CARTON | LOTION | 1 | 4 | |
| 61354-051-21 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 4 | |
| 61354-051-22 | Cream | 1 in 1 CARTON | LOTION | 1 | 4 | |
| 61354-051-22 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 4 | |
| 61354-051-05 | Cream | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 61354-051-05 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 3 | |
| 61354-051-23 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 3 | |
| 61354-051-23 | Cream | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 61354-051-24 | Cream | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 61354-051-24 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 3 | |
| 61354-051-27 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 3 | |
| 61354-051-27 | Cream | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 61354-051-28 | Cream | 1 in 1 CARTON | LOTION | 1 | 3 | |
| 61354-051-28 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 3 | |
| 61354-051-01 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-02 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-02 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-04 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-04 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-06 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-06 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-08 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-08 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-09 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-09 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-10 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-10 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-12 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-12 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-13 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-13 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-14 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-14 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-15 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-15 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-16 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-16 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-17 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-17 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-18 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-18 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-19 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-19 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-20 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-20 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-25 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-25 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-26 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-26 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-29 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-30 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-30 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-33 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-33 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-34 | Cream | 30 mg in 1 TUBE | LOTION | 30 | 2 | |
| 61354-051-34 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-35 | Cream | 15 mg in 1 TUBE | LOTION | 15 | 2 | |
| 61354-051-35 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-36 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-36 | Cream | 15 mg in 1 TUBE | LOTION | 15 | 2 | |
| 61354-051-37 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-37 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-38 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-38 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-39 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-39 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-40 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-40 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-41 | Cream | 3 mg in 1 TUBE | LOTION | 3 | 2 | |
| 61354-051-41 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-42 | Cream | 10 mg in 1 TUBE | LOTION | 10 | 2 | |
| 61354-051-42 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 | |
| 61354-051-43 | Cream | 3 mg in 1 TUBE | LOTION | 3 | 2 | |
| 61354-051-43 | Cream | 1 in 1 CARTON | LOTION | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 4 | Legacy NDC, 2 package rows | 20230620_bbf48997-df4a-1364-e053-2a95a90a4b69.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 4 | Legacy NDC, 2 package rows | 20230211_bbf451db-9968-563a-e053-2995a90ae336.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 4 | Legacy NDC, 2 package rows | 20230211_bbf3c160-fa3e-553a-e053-2995a90a59bd.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 3 | Legacy NDC, 2 package rows | 20230620_bbf4f66b-8e90-2144-e053-2995a90a5058.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 3 | Legacy NDC, 2 package rows | 20230620_bbf57918-7039-fa39-e053-2a95a90a7285.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 3 | Legacy NDC, 2 package rows | 20230211_bc010877-1ccb-9089-e053-2a95a90aa2f8.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 3 | Legacy NDC, 2 package rows | 20230620_bbf54f1b-b444-6f4f-e053-2995a90a6dc1.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 3 | Legacy NDC, 2 package rows | 20230620_bbf504da-d71e-5632-e053-2995a90affe9.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc08ca6d-f737-8292-e053-2a95a90a7fa0.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc03491d-149f-bd0c-e053-2995a90a1355.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc2d328e-2b98-5e46-e053-2a95a90aa965.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc016ece-4848-0f63-e053-2a95a90aee46.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc02885a-2063-0a19-e053-2a95a90aa8ce.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc315495-0f87-2718-e053-2a95a90a372a.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc313e54-5b22-b922-e053-2a95a90a4542.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc01841f-9b4d-065e-e053-2a95a90abe71.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc023f3f-711d-5623-e053-2995a90a983c.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bd0adf0f-eaa7-4d1d-e053-2995a90ae843.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc014ef0-798b-879b-e053-2a95a90a025b.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc3f580a-63e8-c8e9-e053-2995a90aa4f6.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc01bd0b-1a39-1ec1-e053-2995a90aff4f.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc027987-5250-c7f7-e053-2995a90ac4ab.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf54eb5-4bde-67ec-e053-2a95a90a9f46.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 4 package rows | 20230211_bcd4656b-f50c-71ca-e053-2995a90a928b.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc02885a-2060-0a19-e053-2a95a90aa8ce.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc316379-8d87-6553-e053-2a95a90a63d2.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf4c463-89e6-e50a-e053-2a95a90a3942.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc08ca6d-f726-8292-e053-2a95a90a7fa0.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc3f0e8a-7746-7a66-e053-2a95a90a329b.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf52284-8b44-575d-e053-2995a90aac74.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf45560-bc0c-677d-e053-2a95a90ab36e.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf3a93d-9972-6d9d-e053-2a95a90af25f.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc08c038-6630-4dde-e053-2995a90acca7.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bbf0776b-17a1-06d3-e053-2995a90a866e.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc3f8d67-8f4c-435f-e053-2995a90abda4.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc311448-d3aa-67ba-e053-2a95a90a73a2.zip |
| 61354-051 | CREAM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [OXYGEN DEVELOPMENT, LLC] | 2 | Legacy NDC, 2 package rows | 20230211_bc31711a-fc08-72e8-e053-2995a90a94bd.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-051-23 | 61354005123 | 1 TUBE in 1 CARTON (61354-051-23) > 30 mg in 1 TUBE | 1 tube | 2021-02-22 | 0000-00-00 | No | No | Current |