Aveeno Baby Calming Comfort
- Product NDC
- 69968-0629
- 11-digit product format
- 699680629
- Labeler code
- 69968
- Product ID
- 69968-0629_21eb4c57-d7ff-d06c-e063-6394a90ae472
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dimethicone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Kenvue Brands LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-01
- Substance
- DIMETHICONE
- Active strength
- 12 mg/mL
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69968-0629 | 69968-0629-8 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Aveeno Baby Calming Comfort
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 12 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 876980 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 567b1481-b783-45f9-af38-5630c9edf044 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69968-0629-1 | Aveeno Baby Calming Comfort | 532 mL in 1 BOTTLE, PUMP | LOTION | 532 | 5 | |
| 69968-0629-8 | Aveeno Baby Calming Comfort | 227 mL in 1 TUBE | LOTION | 227 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69968-0629 | AVEENO BABY CALMING COMFORT (DIMETHICONE) LOTION [KENVUE BRANDS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241103_567b1481-b783-45f9-af38-5630c9edf044.zip |
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 |
|---|---|---|---|---|---|---|
| Savvy Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE | Savvy Care and Cosmetics | 05ee2662-6a51-6e49-e063-6294a90a4ed7 | 2024-12-19 | Warnings | M016 |
| Health Smart Lavender Baby Petroleum | WHITE PETROLEUM | Home Smart Products | 5828df37-2a42-4129-8e4e-d5ac9c4c9615 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | 980d030a-feaf-4a81-865e-f85c66151380 | 2024-12-19 | Warnings | M016 |
| Baby Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | caf568aa-3889-41ff-835e-875bb6d9ca79 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95 | 2024-12-19 | Warnings | M016 |
| Cars Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 9905b5a4-382e-4d2a-b971-37998c14c330 | 2024-12-19 | Warnings | M016 |
| Health Smart Aloe Vera Petroleum | WHITE PETROLEUM | Home Smart Products | 2671f2ed-af9d-4234-95bf-def368242a78 | 2024-12-19 | Warnings | M016 |
| DCH Scar | ALLANTOIN 0.5% | Derma Care Research Labs, LLC | 00edbc64-9d32-5751-e063-6294a90a400b | 2024-12-19 | Warnings | M016 |
| Bamboobies Diaper Rash | ZINC OXIDE 15% | Derma Care Research Labs, LLC | 0411f5e3-03d2-c512-e063-6394a90a37d3 | 2024-12-19 | Warnings | M016 |
| Maximum Strength Medicated Foot Powder | MEDICATED FOOT POWDER | Jell Pharmaceuticals Pvt. Ltd. | cdaae985-5363-e9d2-e053-2995a90a2682 | 2024-12-18 | Warnings | M016 |
| BABY FRESH SCENT PETROLEUM | WHITE PETROLEUM | Jell Pharmaceuticals Pvt Ltd. | d80d21cf-9463-7184-e053-2995a90a23f3 | 2024-12-18 | Warnings | M016 |
| Health Smart Baby Petroleum | WHITE PETROLEUM | Home Smart Products | edd9d018-c2c9-4a9a-b727-0a92cd463c02 | 2024-12-18 | Warnings | M016 |
| Health Smart Cocoa Butter Petroleum | WHITE PETROLEUM | Home Smart Products | a65c8267-d34f-4542-a7ca-5180e860a03d | 2024-12-18 | Warnings | M016 |
| Princess Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 6d9c92bf-9263-40a4-acac-5c3f0b08c69d | 2024-12-18 | Warnings | M016 |
| Meijer Petroleum Jelly | WHITE PETROLATUM | Meijer Distribution, Inc | b299cf2a-2c6a-68f4-e053-2995a90a5bd7 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 29945734-4ea6-b702-e063-6294a90ae6f2 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Strategic Sourcing Services, LLC | 29946912-9794-8a8e-e063-6394a90a279e | 2024-12-18 | Warnings | M016 |
| Caring Mills Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | fbbfa780-0e2b-1874-e053-6394a90a5eeb | 2024-12-18 | Warnings | M016 |
| Serawise Eczema Rescue | OATMEAL | DrAnaMaria.com LLC | e805866a-2349-4b86-bc83-a7c859cb9403 | 2024-12-18 | Warnings | M016 |
| TheraCare Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | d6fad49b-8a49-7f7c-e053-2a95a90ae638 | 2024-12-18 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 876980 | dimethicone 1.2 % Topical Lotion | PSN | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 12 MG/ML Topical Lotion | SCD | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
| 876980 | dimethicone 1.2 % Topical Lotion | SY | 567b1481-b783-45f9-af38-5630c9edf044 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69968-0629-1 | 69968062901 | 532 mL in 1 BOTTLE, PUMP (69968-0629-1) | 532 ml | 2020-06-01 | 0000-00-00 | No | No | Current |
| 69968-0629-8 | 69968062908 | 227 mL in 1 TUBE | 227 ml | Historical |